It will also discuss the Simplify Medical transaction at that time. Biologics - NuVasive Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. PLoS ONE 2011;6(10):1-8. Expected delivery: 3 weeks. Telephone 1 858 9091800. Based on review of publicly available materials at the time of this release. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. 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. PDF NuVasive, Incorporated Ms. Daniela Mahan, Esq., RAC 7475 Lusk Blvd Unhappy? 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 provides patient support and surgeon education. Get your money back!. Address 7475 Lusk Blvd, San Diego, California, 92121. DLA Piper is serving as NuVasives legal counsel. One position. PDF Document Title: Visual and Cosmetic Standards for Manufacturing 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 Globus Medical eyes acquisition of spinal implant maker NuVasive UPDATE: Potential Concerns with NuVasive Precice Devices z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. Biomater Sci 2018;6:136-45. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. 'VUJ)(h. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. COCCYX ZONE OF SPINE FOR. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. All rights reserved. Retroperitoneal access 3. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. PDF San Diego, CA 92121 PCM - Food and Drug Administration ALIF - NuVasive %%EOF This service located at Oisto.com is a website owned and operated by Oisto. D. Device Description. multi-level pathologies. WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. NuVasive is the fastest growing, full-line spine company. Quantity: Robert Eastlack and Gregory Mundis. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; 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. Photos are for illustration purposes only and may not depict the exact item. Lehr MA, Oner CF, Delawi D, et al. NuVasive Company Profile - Office Locations, Competitors, Revenue In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. 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. To learn more, visit www.simplifymedical.com. Excluding VAT and shipping. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. List of devices made by the manufacturer NUVASIVE, INC. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. 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. Simplify Medical is located in Sunnyvale, California. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. See here for a complete list of exchanges and delays. 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). Peer-to-peer discussion between Drs. Expected delivery: 3 weeks. Returns are simple. 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 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. WestCMR does not provide advice, training, or clinical support. NuVasive offers solutions to alleviate patient symptoms. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. PDF User Manual - Nuwave Cpap 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. 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. %PDF-1.4 % The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. Nov 15 (Reuters) - Globus Medical Inc (GMED.N) has approached NuVasive Inc (NUVA.O), a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar with the matter said. The SRS-Schwab adult spinal deformity classification: All Trademarks & Logos belong to their respective owners. endif; ?> Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE The materials on this website are for your general educational information only. 0 NuVasive, 8050015, NuVasive NVM5 EMG Needle Module - eSutures $1,299.99. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. NuVasive Inc Company Profile - GlobalData devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). 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. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Do not implant more than two devices in a patient at once. $650.00. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. PDF NUVASIVE' 1 Nu Vasive Sage Lateral Plate System '4 It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. All products sold by WestCMR are in-date. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. NuVasive is developing the operating room of the future. 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 . NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. PCF - NuVasive - PDF Catalogs | Technical Documentation Becoming the number one partner in pediatrics. Make sure cookies are enabled in your browser. Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. 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. 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. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! 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). Prices excluding VAT and shipping. 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. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. PDF eXtreme - SMISS 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. Information you read on this website cannot replace the relationship that you have with your healthcare professional. gtag('js', new Date()); 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. Polini A, Pisignano D, Parodi M, et al. function gtag(){dataLayer.push(arguments);} About NuVasive *Data on file. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. For the best experience on our site, be sure to turn on Javascript in your browser. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Product images are for display only. The store will not work correctly in the case when cookies are disabled. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. 4. 789 0 obj <> endobj ET / 1:30 p.m. PT to discuss these results. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. 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
nuvasive product catalog pdf