510(k) clearance
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Hospitals
Stryker’s AVAflex® Vertebral Balloon System Receives FDA 510(k) Clearance
Kalamazoo, Michigan, USA – March 7, 2017 – Stryker announced today that its AVAflex Balloon System has received FDA 510(k)…
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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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Spine
NuVasive Receives First Ever FDA 510(k) Clearance of Cervical Corpectomy Cage
SAN DIEGO, CA–(Marketwired – October 12, 2015) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery…
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Zyga Receives 510(k) Clearance for SImmetry® Sacroiliac Joint Fusion System Updates
MINNETONKA, Minn., Aug. 13, 2015 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of…
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Hospitals
FH Ortho Gains FDA 510(k) Clearance for Orthopedic Arthrodesis Nail
FH Ortho has secured FDA 510(k) clearance to market its Calcanail system for heel fractures and rear foot fusion surgery…
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Extremities
FH Ortho Receives FDA 510(K) Clearance for Its Arrow® Reverse Shoulder Long Keel & Short Keel Glenoid Base
CHICAGO–(BUSINESS WIRE)–FH Ortho, maker of thoughtfully designed orthopedic devices, instruments and procedures for orthopedic surgeons around the world, announces it…
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