510k
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Hospitals
K2M Enhances 3D-Printed Spine Portfolio Following FDA Clearance of Two CASCADIA™ Interbody Systems Featuring Lamellar 3D Titanium Technology™
LEESBURG, Va., June 01, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (KTWO) (the “Company” or “K2M”), a global medical…
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Hospitals
Bone Index Receives FDA 510(k) Clearance for the Bindex® Point-of-care Instrument to Help Physicians in Diagnosing Osteoporosis
KUOPIO, Finland, May 16, 2016 /PRNewswire/ — Bone Index Ltd., one of Europe’s top new manufacturers of medical devices, has…
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Extremities
First Ray Receives FDA 510(k) Clearance for CortiClamp™ Small Bone Fixation System
LOGAN, Utah, May 16, 2016 /PRNewswire/ — First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for…
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Spine
Orthofix Announces 510(k) Clearance and US Limited Market Launch of FORZA PTC Interbody Spacer System
May 16, 2016 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced the 510(k)…
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Hospitals
Revival™ Modular Revision Stem gains 510(k) clearance
3 May 2016 Corin is pleased to announce 510(k) clearance in the US for a range of modular titanium…
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Extremities
First Ray Receives FDA 510(k) Clearance for Stealth Staple™
LOGAN, Utah, May 3, 2016 /PRNewswire/ — First Ray, a start-up medical device company focused on advanced surgical devices for improving…
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Spine
Intelligent Implant Systems Receives 510(k) Clearance for Two-Level Revolution™
Intelligent Implant Systems announced today that the two-level components for the Revolution™ Spinal System were cleared by the FDA via…
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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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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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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
CareFusion Receives Two 510(k) Clearances For Spine Products
FRANKLIN LAKES, N.J., Dec. 10, 2015 /PRNewswire/ — CareFusion, a BD company (BDX), today announced the U.S. Food and Drug Administration…
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Hospitals
39 orthopedic, spine devices receive FDA 510(k) clearance in October
By Laura Dyrda The Food and Drug Administration granted 39 orthopedic- and spine-related clearances in October. 1. Valeo Spacer System and Valeo…
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Hospitals
Prosidyan Announces FDA 510(k) Clearance of FIBERGRAFT BG Morsels for Postero-Lateral Spinal Fusion
Warren, NJ, November 16, 2015 –(PR.com)– NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today that it…
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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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