clearance
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Spine
Implanet granted regulatory clearance in the U.S. (510k) and Europe (CE) for its new JAZZ Lock® implant
Bordeaux, Boston, 5 April 2016 – IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and…
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Spine
Tyber Medical announces 510(k) FDA clearance for modified surface treatment
Tyber Medical LLC announced it has received FDA clearance for its BioTy, a modified surface treatment to use on the…
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Extremities
Zimmer Biomet Announces FDA Clearance for Compatibility of Nexel™ Total Elbow and Comprehensive® Segmental Revision System
WARSAW, Ind., March 3, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare,…
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Hospitals
510(k) Clearance “Corrected” 19 Years after Original Clearance
By Jeffrey N. Gibbs & Allyson B. Mullen Imagine that you were working at a device company and you…
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Extremities
Extremity Medical announces the 510k clearance of the Align Ankle Fusion System
March 29, 2016- Parsippany, NJ: Extremity Medical, LLC announces that it has received 510(k) clearance from the FDA to market…
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Recon
Tenex Health Secures FDA Clearance for the TX2 MicroTip, Providing a Minimally Invasive Solution for Chronic Tendinosis
LAKE FOREST, Calif., March 29, 2016 /PRNewswire/ — Tenex Health Inc. has obtained FDA 510K clearance for its new TX2 MicroTip.…
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Extremities
Carestream Submits Application for FDA 510(k) Clearance For Its OnSight 3D Extremity System
ROCHESTER, N.Y.–(BUSINESS WIRE)–Carestream Health has filed a 510(k) application with the FDA for clearance of itsCARESTREAM OnSight 3D Extremity System…
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Hospitals
Life Spine® Announces FDA Clearance of GRUVE™ Anterior Cervical Plate System
HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of…
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CareFusion receives two 510(k) clearances for spine augmentation devices
CareFusion announced the FDA 510(k) clearances for its 13-gauge AVAmax vertebral balloon system and its 11-gauge AVAmax vertebral balloon system.…
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Hospitals
Medtronic Announces FDA Approval of Infuse® Bone Graft for Three New Spine Surgery Indications
December 11, 2015 – Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of additional spine…
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Hospitals
Siemens Receives FDA Clearance for Multitom Rax Robotic X-ray System
MALVERN, Pa.–(BUSINESS WIRE)–Siemens Healthcare has announced that the U.S. Food and Drug Administration (FDA) has cleared the Multitom Rax (Robotic…
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Vertera Spine Announces FDA Clearance of the First Surface Porous PEEK Interbody Fusion Device
ATLANTA, Oct. 6, 2015 /PRNewswire/ — Vertera Spine, a developer of medical devices with advanced functional surface technologies for spine applications, today announced…
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Spinal Elements’ Lotus System gets FDA clearance for new indication: 5 key notes
By Laura Dyrda Spinal Elements received FDA clearance to market the Lotus Posterior Cervical/Thoracic Spinal System with expanded indications for…
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Hospitals
Photo Release — Xtant Medical Announces FDA Clearance of the Aranax(TM) Cervical Plate
BELGRADE, Mont., Sept. 9, 2015 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (OTCQX:BONE), a leader in the development of regenerative…
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Nextremity Solutions, Inc. Receives FDA 510(k) Approval for the Arcus(TM) Staple System
WARSAW, Ind., Sept. 8, 2015 (GLOBE NEWSWIRE) — Nextremity Solutions, Inc., a pure-play foot and ankle company, recently received 510(k)…
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