Thu, October 4th, 2018. 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. NuVasive logo printed in 1 colour Prices (minimum order quantity 10 pieces) 10 - 24 pieces - 22,65 25 - 49 pieces - 19,30 50 - 100 pieces - 17,60 more than 100 pieces - please contact us for a new quote. Three New Biologic Products for Spine Surgery. Intelligently designed for fusion. PCF - NuVasive - PDF Catalogs | Technical Documentation The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. The site is secure. At NuVasive, we transform surgery, advanced care, and change lives. Sign in to add this product to your favorites! Expected delivery: 2 weeks. Forward-Looking Statements All products | NuVasive Webshop 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. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. 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 All products sold by WestCMR are in-date. Product images are for display only. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Simplify Medical is located in Sunnyvale, California. Biomater Sci 2018;6:136-45. 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. Investor Conference Call NuVasive is developing the operating room of the future. Expected delivery: 3 weeks. This service located at Oisto.com is a website owned and operated by Oisto. 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. You don't have to face this journey alone. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. As of date of publication, March 2017; data on file. All rights reserved. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. All quotes delayed a minimum of 15 minutes. 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. 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. NUVASIVE: 2012022 SKU# 2012022-WE1. Expected delivery: 2 weeks. 3. Based on review of publicly available materials at the time of this release. 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. Simplify Medicals technology was designed to offer surgeons best-in-class capabilities for cTDR across key performance functions, including: NuVasive will leverage its commercial and distribution channels in the U.S. and international markets to drive utilization of the Simplify Disc. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! NuVasive funded the upfront payment at closing using available cash on hand. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. 1Simplify Cervical Artificial Disc P200022. We do not practice medicine or provide medical services or advice as a part of this website. The San Diego, CA-based company said the RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce . Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. 4. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 1 Terran J, Schwab F, Shaffrey CI, et al. Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. $1,299.99. Retroperitoneal access 3. 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. PDF NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs System The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. Telephone 1 858 9091800. Home | NuVasive CODE: NS10000565. The materials on this website are for your general educational information only. 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. Expected delivery: 3 weeks. 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. Evaluate additional biocompatibility assessments intended to address specific biocompatibility concerns with all Precice devices and collect additional data to better understand the risks to patients. Read the press release Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. 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). Our Standards: The Thomson Reuters Trust Principles. Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. 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. Login - NuVasive Company Store - Direct EDJE NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. %PDF-1.5 % Please close the page and access the Company Store via Okta. 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. Prices excluding VAT and shipping. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. if( $robots ) : ?> The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. endstream endobj startxref We are excited about the opportunities this acquisition creates as we work to optimize the surgeon experience, advance the standard of care, and create value for shareholders.. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Canadian pipeline operator Enbridge Inc said on Monday it would acquire Aitken Creek natural gas storage facility in British Columbia (B.C.) Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. The Instructions for Use for titanium-based Precice devices have been updated to include: For Titanium-Based Precice devices (Precice IMLL, Precice Short, Precice Freedom, Precice Unyte): Note: Stainless steel-based Precice devices remain recalled from the U.S. market. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. ALIF - NuVasive NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. PDF San Diego, CA 92121 PCM - Food and Drug Administration Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. 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). 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. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. NuVasive Company Profile - Office Locations, Competitors, Revenue endif; ?> Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. 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. Implant insertion NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. NuVasive is the fastest growing, full-line spine company. Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. 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. PDF NUVASIVE' 1 Nu Vasive Sage Lateral Plate System '4 Advisors You have not been assigned a username and password. 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. *Data on file. 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 This power bank is suitable for charging any device. WestCMR does not provide advice, training, or clinical support. Prices excluding VAT and shipping. About NuVasive Excluding VAT and shipping. 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. Get your money back!. combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- 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. Learn how intelligent surgery can change your practice. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P $650.00. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. 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.

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