All rights reserved. 789 0 obj <> endobj Price: $5.00 per kit. BOX8-1Five Key Steps for Performing the XLIF Procedure 1. 3. 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. To learn more, visit www.simplifymedical.com. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. Spine 2020;45(14):944-51. These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. Expected delivery: 3 weeks. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. Plenty of storage and clever organisation for life on the go, Store a 15.6" laptop in the dedicated compartment padded with EVA Impact Foam for extra protection, Spacious main compartment with structured slip pockets for a tablet, For organising a portable charger, cables and accessories, Lightweight collapsible pitchfork made of high-quality ABS plastic, Equipped with a magnetic ball marker with Nuvasive logo-doming, Kobaldeck playing cards are of absolute top quality, Back of cards and box are printed with Nuvasive logo, Receptacles for Europe, USA/Japan, Australia/China, All international security-relevant standards and norms, Keeps your drinks cold for 8 hours and hot for 5, Height 25cm, diameter 7cm - Volume: 500 ml, Ergonomic design provides a comfortable fit for your ears, Handy pocket-size power booster - 5000mah. 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. Information you read on this website cannot replace the relationship that you have with your healthcare professional. The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. 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. or more while undergoing treatment, and. Before sharing sensitive information, make sure you're on a federal government site. All Trademarks referred to are the property of their respective owners. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. Duan R, Barbieri D, Luo X, et al. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. 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. NuVasive is developing the operating room of the future. var base_url = "https://www.medicaldevices24.com/"; Expected delivery: 2 weeks. 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. 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. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. 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. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. That no more than two devices should be implanted at a time. All products sold by WestCMR are in-date. 0 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Excluding VAT and shipping. 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. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE Address 7475 Lusk Blvd, San Diego, California, 92121. *Data on file. Expected delivery: 3 weeks. 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. Copyright 2022 Oisto. All quotes delayed a minimum of 15 minutes. 'VUJ)(h. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? 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. At NuVasive, we transform surgery, advanced care, and change lives. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. NuVasive provides patient support and surgeon education. 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). 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. Elizabeth Hofheinz, M.P.H., M.Ed. The .gov means its official.Federal government websites often end in .gov or .mil. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. The industry leader for online information for tax, accounting and finance professionals. Forward-Looking Statements Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl %PDF-1.5 % Simplify Medical is located in Sunnyvale, California. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. endif; ?> Neurocare Products. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. D. Device Description At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. 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. 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. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. Advisors See here for a complete list of exchanges and delays. Get your money back!. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. Learn more about the value of Biologics Information you need When fusion is recommended One comprehensive system. In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. Product Code: NKB, KWP, MNI, MNH, KWQ C. Predicate Devices The subject Nu Vasive Polyaxial Spinal Screws are substantially equivalent to the PreceptTM (K1025 14), Armada (K092287), and SplzeRx PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive. We do not practice medicine or provide medical services or advice as a part of this website. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. Website www.nuvasive.com. Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. Malone, H., Mundis, G. M., Jr., Collier, M, et al. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. ET / 1:30 p.m. PT to discuss these results. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. Learn how intelligent surgery can change your practice. As of date of publication, March 2017; data on file. $749.00. An integrated technology platform to enable better spine surgery. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream %PDF-1.4 % devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). $650.00. The Sage Lateral Plate System Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. Expected delivery: 2 weeks. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. endstream endobj startxref 1997-2023 WestCMR. Becoming the number one partner in pediatrics. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. COMPANY CONFIDENTIAL. Lehr MA, Oner CF, Delawi D, et al. The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precice devices made from stainless steel and titanium. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. Quantity: NV Dynamic Stimulation Clip and Inline Activator. 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). 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. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. Polini A, Pisignano D, Parodi M, et al. Excluding VAT and shipping. Neurostimulators & Components. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. 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. Thu, October 4th, 2018. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. gtag('js', new Date()); Our Standards: The Thomson Reuters Trust Principles. 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. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. $5,499.99. The subject 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. 2. 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. 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 Voluntary reports can be submitted through, Device manufacturers and user facilities must comply with the applicable, Health care personnel employed by facilities that are subject to the. The Companys comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. 8050015: NuVasive NVM5 EMG Needle Module. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. Product images are for display only. Journal of Neurosurgery Spine. The SRS-Schwab adult spinal deformity classification: About NuVasive NuVasive provides patient support and surgeon education. NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. The materials on this website are for your general educational information only. Intelligently designed for fusion. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| Rethink how you buy and sell surgical supplies. Excluding VAT and shipping. 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. We do not practice medicine or provide medical services or advice as a part of this website. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f Disc space preparation 5. All rights reserved. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. 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. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. Three New Biologic Products for Spine Surgery. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. One position. (This story corrected name of Globus Medical in the headline from Global Medical). The materials on this website are for your general educational information only. 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). 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. 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. Photos are for illustration purposes only and may not depict the exact item. ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. Do not implant more than two devices in a patient at once. Excluding VAT and shipping. Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. 4. WestCMR does not provide advice, training, or clinical support. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. 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. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. 1.0 Purpose. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. xZrJ]e7,[Uv%d|7@$$! Transaction Details multi-level pathologies. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. Excluding VAT and shipping. 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. NuVasive offers solutions to alleviate patient symptoms. At NuVasive, we aspire to change a patients life every minute. 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 .
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