The site is secure. 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). Osteocel is human tissue donated specifically for human clinical use. if( $robots ) : ?> ALIF - NuVasive NuVasive funded the upfront payment at closing using available cash on hand. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Open the catalog to page 2 What is causing my pain? NuVasive is the fastest growing, full-line spine company. NuVasive provides patient support and surgeon education. PDF San Diego, CA 92121 PCM - Food and Drug Administration /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Robert Eastlack and Gregory Mundis. Do not implant more than two devices in a patient at once. An integrated technology platform to enable better spine surgery. %%EOF Eastlack and Mundis as they discuss, Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion?, recently published in the Journal of Neurosurgery Spine. This service located at Oisto.com is a website owned and operated by Oisto. The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. hb```b````e`ad@ A(GcG!O HW7o.[S.8{bZx{f(*m(!$ d9>k=ggx rM},(qS>gz}":IHH]1s1@lL j,l l@6kzGkFGkfTt4E# `(AokavH8XVh|Pi\P(d. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f 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). You should always talk to your healthcare professional for diagnosis and treatment. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. At NuVasive, we aspire to change a patients life every minute. Telephone 1 858 9091800. Prices excluding VAT and shipping. 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. COCCYX ZONE OF SPINE FOR. 1 Terran J, Schwab F, Shaffrey CI, et al. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. 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. 'VUJ)(h. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. Product Code: LLZ C. Predicate Devices The subject NuVasive NuvaLine is substantially equivalent to the primary predicate NuVasive NuvaLine Mobile App (K162647) and additional reference devices NuVasive NVM5 System (K152942), Nemaris Surgimap 2.0 (K141669), and NucleusHealth Nucleus Image Mangement System (K171130). Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. $650.00. As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices. Precice devices are implants intended for patients 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones. Price: $5.00 per kit. For care of patients who currently have one of these devices and weigh less than 50 pounds and/or have more than two devices implanted, the health care team should assess treatment progression and consider removal of nails promptly at the end of treatment. In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. 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 . 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. This power bank is suitable for charging any device. Advisors As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. 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. 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. NuVasive is developing the operating room of the future. An official website of the United States government, : NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. Transpsoas access 4. Propel DBM Fibers and Propel DBM Sponge are 100% bone and are intended for homologous use in the repair, replacement, or reconstruction of skeletal defects. PDF NuVasive, Incorporated September 26, 2019 Mr. Mark Job Responsible Photos are for illustration purposes only and may not depict the exact item. List of devices made by the manufacturer NUVASIVE, INC. Quantity: Prices excluding VAT and shipping. Excluding VAT and shipping. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. function gtag(){dataLayer.push(arguments);} The store will not work correctly in the case when cookies are disabled. Appropriate patient positioning 2. NuVasive is now able to address all key segments of the cervical spine by offering comprehensive, procedurally integrated solutions across anterior cervical discectomy and fusion (ACDF), posterior cervical fusion (PCF), and cTDR procedures. The SRS-Schwab adult spinal deformity classification: Duan R, Barbieri D, Luo X, et al. 50 - 99 pieces - 8,75. NuVasive is developing the operating room of the future. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. CODE: NS10000565. 1.0 Purpose. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. Excluding VAT and shipping. multi-level pathologies. The subject Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. 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. The unique microarchitecture of Attrax drives the differentiation of mesenchymal stem cells (MSCs) into bone-forming osteoblasts without added growth factors.2 The optimized microarchitecture of Attrax is engineered using tightly controlled parameters for a defined micropore size distribution within 0.3 to 1.1 microns, demonstrated to initiate greater bone formation compared to traditional ceramics.3, Attrax Putty is one of only a few bone grafting devices on the market supported by a Level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions.4. UPDATE: Potential Concerns with NuVasive Precice Devices Based on review of publicly available materials at the time of this release. This is why we show up every day, united and committed to our vision. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. NuVasive is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. 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 NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. NuVasive Launches Modulus ALIF. Copyright 2022 Oisto. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. NuVasive offers solutions to alleviate patient symptoms. Based on review of publicly available materials at the time of this release. Sign in to add this product to your favorites! 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. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream Simplify Cervical Artificial Disc provides NuVasive most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment, Expands growth opportunities and further differentiates Companys comprehensive portfolio across ACDF, PCF, and cTDR procedures. Previously, on April 5, 2021, NuVasive had posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. gtag('js', new Date()); 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. 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. NuVasive is developing the operating room of the future. 1Simplify Cervical Artificial Disc P200022. ET / 1:30 p.m. PT to discuss these results. The contents of this Site, including but not limited to the text and images herein and their arrangements, unless otherwise noted, are the copyrighted material of Oisto. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! Information you read on this website cannot replace the relationship that you have with your healthcare professional. You don't have to face this journey alone. See here for a complete list of exchanges and delays. Globus Medical eyes acquisition of spinal implant maker NuVasive Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. Combining the Simplify Disc with NuVasives C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. 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 its C360 portfolio. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. Neurostimulators & Components. 2Data on file. 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. NuVasive is the fastest growing, full-line spine company. D. Device Description 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. $1,299.99. PDF Document Title: Visual and Cosmetic Standards for Manufacturing We do not practice medicine or provide medical services or advice as a part of this website. The .gov means its official.Federal government websites often end in .gov or .mil. One position. Excluding VAT and shipping. Leading Independent Proxy Advisory Firm Glass Lewis Joins ISS in Recommending NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, Leading Independent Proxy Advisory Firm ISS Recommends NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, NuVasive to Participate in Upcoming Global Spine Conferences, NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients. All Trademarks & Logos belong to their respective owners. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. About Simplify Medical The discussions between the companies are preliminary and there is no certainty that a deal will be reached, the sources added, requesting anonymity because the matter is confidential. Learn more about the value of Biologics Information you need When fusion is recommended The X360 System is a comprehensive approach to lateral single-position surgery powered by Surgical Intelligence, an ecosystem of technologies enabling safer, faster, smarter surgery. Expected delivery: 3 weeks. 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). 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. Excluding VAT and shipping. 1. 2.0 Scope Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. As demonstrated by the strong clinical data and the unique design characteristics of the Simplify Disc, we share NuVasives focus on outcome-driven innovation, said David Hovda, president and chief executive officer of Simplify Medical. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. Unhappy? The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts.
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