It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. The website is intended to provide information that might be of interest to users. The Simplify Disc is supported by level-1 evidence through the FDA investigational device exemption (IDE) study1 and was found to be clinically superior to ACDF in the randomized controlled trial. Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. This power bank is suitable for charging any device. Height 25cm, diameter 7cm - Volume: 500 ml. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. 789 0 obj <> endobj Headquarters United States of America. endstream endobj startxref Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. NuVasive offers solutions to alleviate patient symptoms. 1Simplify Cervical Artificial Disc P200022. if( $robots ) : ?> xZrJ]e7,[Uv%d|7@$$! var site_url = "https://www.medicaldevices24.com/"; hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl You should always talk to your healthcare professional for diagnosis and treatment. NuVasive is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! NuVasive is the fastest growing, full-line spine company. 2.0 Scope Journal of Neurosurgery Spine. Copyright 2022 Oisto. Transaction Details The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. On April 5, 2021, NuVasive posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. Information you read on this website cannot replace the relationship that you have with your healthcare professional. About Simplify Medical z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f Spine 2020;45(14):944-51. Photos are for illustration purposes only and may not depict the exact item. 888 0 obj <>stream Intelligently designed for fusion. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. Alignment. The integration of XLIF, XALIF, and XFixation into a single platform enables surgeons to treat a patient without repositioning, which may reduce patient time under anesthesia and hospital costs. Exclusive news, data and analytics for financial market professionals, Reporting by Greg Roumeliotis in New York, US FDA declines to approve Ascendis' hormone disorder therapy, Astellas Pharma buys Iveric Bio for $5.9 billion, Pfizer, BioNTech propose EU pays half for each cancelled COVID dose, Financial Times reports, Indian cough syrup: mystery middleman may be new clue, Enbridge acquires gas storage facility in British Columbia for $295 million, Adani-owned NDTV profit plunges about 98% on weak advertising demand, U.S. FAA opens new direct plane routes ahead of summer travel, Russia temporarily halts gas supply to Armenia for planned maintenance, Norwegian Cruise lifts profit forecast on higher ticket prices, steady demand. D. Device Description. Polini A, Pisignano D, Parodi M, et al. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. Elizabeth Hofheinz, M.P.H., M.Ed. We do not practice medicine or provide medical services or advice as a part of this website. or more while undergoing treatment, and. An official website of the United States government, : $749.00. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive offers solutions to alleviate patient symptoms. COCCYX ZONE OF SPINE FOR. function gtag(){dataLayer.push(arguments);} Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. San Diego, California 92121 Re: K210214 Trade/Device Name: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX The potential combination would accelerate consolidation in the spine surgery market, where smaller players are turning to dealmaking to compete against the likes of Johnson & Johnson (JNJ.N), Medtronic Plc (MDT.N) and Zimmer Biomet Holdings Inc (ZBH.N). ET / 1:30 p.m. PT to discuss these results. The industry leader for online information for tax, accounting and finance professionals. Lehr MA, Oner CF, Delawi D, et al. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. D. Device Description The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (TI-SI). ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. All rights reserved. (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121 Re: K191974 Trade/Device Name: NuVasive AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV See here for a complete list of exchanges and delays. NuVasive is headquartered in San Diego, California, the US. By using modern education principles, competency-based curriculum, and multi-modal learning pathways, the CPD team and its dedicated surgeon faculty provide an unparalleled learning experience for surgeons and their staff around the globe. At NuVasive, we aspire to change a patients life every minute. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| Reimagine cervical spine surgery. Prices excluding VAT and shipping. Excluding VAT and shipping. 2Data on file. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. 2020 - Propel DBM Putty Plus and Gel Plus contain added cancellous chips and serve as a bone graft extender (extremities, posterolateral spine, pelvis) and bone void filler of the extremities and pelvis. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to . Canadian pipeline operator Enbridge Inc said on Monday it would acquire Aitken Creek natural gas storage facility in British Columbia (B.C.) Expected delivery: 3 weeks. 2. Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. We do not practice medicine or provide medical services or advice as a part of this website. Prices excluding VAT and shipping. Sign in to add this product to your favorites! Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. If the item is subject to FDA regulation, seller must verify your status as an authorized purchaser of this item before shipping of the item. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Pursuant to the terms of the transaction agreement, NuVasive made an upfront payment to Simplify Medical of $150.0 million at closing, subject to customary purchase price adjustments, and agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales from products incorporating the Simplify Cervical Artificial Disc technology. If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230). NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. Learn how intelligent surgery can change your practice. JavaScript seems to be disabled in your browser. Retroperitoneal access 3. The acquisition of Simplify Medical advances our previously communicated long-term growth strategy by both expanding, and further distinguishing, our portfolio with industry-leading innovation, said J. Christopher Barry, chief executive officer of NuVasive. The FDA continues to work with NuVasive to: The FDA will continue to keep health care providers and the public informed as new or additional information becomes available. NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasives results to differ materially from historical results or those expressed or implied by such forward-looking statements. One comprehensive system. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. NuVasive is developing the operating room of the future. Address 7475 Lusk Blvd, San Diego, California, 92121. This service located at Oisto.com is a website owned and operated by Oisto. At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. Expected delivery: 2 weeks. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 13,8750 - 99 pieces - 8,75100 - 200 pieces - 7,86more than 200 pieces - please contact us for a new quote. DLA Piper is serving as NuVasives legal counsel. Make sure cookies are enabled in your browser. Surgical efficiency meets reliable versatility. Get your money back!. Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life. Information you read on this website cannot replace the relationship that you have with your healthcare professional. About NuVasive The materials on this website are for your general educational information only. It will also discuss the Simplify Medical transaction at that time. We believe in the importance of preoperative decision-making and support toolsinformed by data and clinical experiencepaired with novel, intraoperative tools to execute a surgeon-specific plan. NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. BOX8-1Five Key Steps for Performing the XLIF Procedure 1. Adhering to the three core principles of Advanced Materials ScienceSurface, Structure, and ImagingNuVasive has pioneered design and manufacturing methods that combine the inherent benefits of porosity with the advantageous material properties of PEEK and titanium to create implants intelligently designed for fusion. In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. 3. To learn more, visit www.simplifymedical.com. An integrated technology platform to enable better spine surgery. Expected delivery: 2 weeks. Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 Expected delivery: 3 weeks. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. You should always talk to your healthcare professional for diagnosis and treatment. Open the catalog to page 2 What is causing my pain? Prices(minimum order quantity 10 pieces)10 - 24 pieces - 22,6525 - 49 pieces - 19,3050 - 100 pieces - 17,60more than 100 pieces - please contact us for a new quote.Expected delivery: 3 weeks. These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. The three essential biologic mechanisms involved in complete bone grafts include osteoconduction (a scaffold for the reparative growth of the natural bone), osteoinduction (signals encouraging undifferentiated cells to become active osteoblasts), and osteogenesis (living bone cells in the graft material contribute to bone remodeling). The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. 1 Terran J, Schwab F, Shaffrey CI, et al. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. NuVasive plans to announce tomorrow its financial results for the fourth quarter and full year ended Dec. 31, 2020. Biomater Sci 2018;6:136-45. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream iMedSales is a premier surgical and medical equipment supplier that provides a combina Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~, Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image, STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG, Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill, Karl Storz 22220154 HD Image 1 H3M Microscope, Dr 3-Chip Camera, Karl Storz 20132020 Xenon Light Source 175 Watt ~ Lamp only has 13 hours, Medical Blue Nitrile Gloves Latex Free, Powder Free, Textured, Disposable, Non-Sterile 100 pieces per box of 1. All rights reserved. 50 - 99 pieces - 8,75. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics' Precice devices made from. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. Propel DBM is donated human bone that has been demineralized to remove the minerals and cells contained in the bone while retaining the collagen matrix and growth factors, including bone morphogenetic proteins, inherent to the tissue. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. If so, do not buy this item unless you are an authorized purchaser. San Diego, CA 92121 PCM THE CERVICAL DISC SYSTEM INSTRUCTIONS FOR USE Rx Only GRAPHICAL SYMBOLS Read Instructions Before Use Single Use Only Catalog Number Lot Number STLE RSterile by Irradiation Non-Sterile, Sterilize by Steam before Use Manufacturer Use By HOW SUPPLIED Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. The materials on this website are for your general educational information only. devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. (Top row): NuVasive DBM putty and gel and NuVasive amniotic membrane DS (Bottom Row): Traditional bone allograft and DBM fibers / Courtesy of NuVasive, Inc. NuVasive, Inc. has announced U.S. commercial launch of three new biologics . Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. Forward-looking statements include, but are not limited to, statements about the potential benefits of the acquisition, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. The .gov means its official.Federal government websites often end in .gov or .mil. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. Appropriate patient positioning 2. *Data on file. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Telephone 1 858 9091800. The materials on this website are for your general educational information only. Excluding VAT and shipping. Fusion is a surgical procedure in which one or more of the vertebrae of the spine are joined together (fused) so that motion no longer occurs between them. Following the commercial launch of the NuVasive ACP system and the Simplify Cervical Disc, we have recently introduced a posterior cervical fusion solution, Reline Cervical. 'VUJ)(h. %PDF-1.5 % Duan R, Barbieri D, Luo X, et al. Learn more about the value of Biologics Information you need When fusion is recommended Prices(minimum order quantity 25 pieces)25 - 49 pieces - 17,7550 - 99 pieces - 15,90100 - 150 pieces - 14,70more than 150 pieces - please contact us for a new quote. The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. The subject Returns are simple. 809 0 obj <>/Filter/FlateDecode/ID[]/Index[789 100]/Info 788 0 R/Length 99/Prev 1608803/Root 790 0 R/Size 889/Type/XRef/W[1 2 1]>>stream Osteocel provides a complete and physiologic bone graft that contains all of the necessary components for bone growth: the cells, the signals, and the scaffold. Globus Medical Inc has approached NuVasive Inc , a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar . gtag('config', 'G-XBG07ECKJ5'); BOLTS FOR SMALL CAGE COROENT INTERLOCK NUVASIVE, CERVICAL DISC PROSTHESIS CERPASS NUVASIVE, CONNECTOR AND NUT CLOSURE STERILE - VUEPOINT II, COROENT CAGE SMALL SCREW INTERLOCK NUVASIVE, COROENT LARGE OBLIQUE STERILE - CAGE INTERSOMATICO, COROENT SMALL INTERLOCK II - CAGE INTERBODY, COROENT XL TITANIUM BARREN - CAGE INTERBODY, DYNAMIC STIMULATION AND INLINE CLIP APPLICATOR, HOOK AND NUT CLOSURE STERILE - VUEPOINT II, LIVES FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, NV M5 XLIF KIT WIRE KIRSCHNER AND DILATOR, SCREWS E NUT CLOSURE STERILE - VUEPOINT II, STAPLE FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, SYSTEM COROENT XL STERILE - CAGE INTERBODY, THE PAS-II PEDICLE INSULATED SYSTEM ACCESS, Complete classification of medical devices. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. The SRS-Schwab adult spinal deformity classification: NV Dynamic Stimulation Clip and Inline Activator. We do not practice medicine or provide medical services or advice as a part of this website. gtag('js', new Date()); $1,299.99. NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. As of date of publication, March 2017; data on file. Neurostimulators & Components. For the best experience on our site, be sure to turn on Javascript in your browser. The store will not work correctly in the case when cookies are disabled. On November 30, 2021, NuVasive issued a field safety notice to inform health care providers of updated labeling and the ship hold in the United States was lifted for titanium-based Precice devices.
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