510(k) clearance
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Hospitals
Exactech Receives 510(k) Clearance for Equinoxe® Stemless Shoulder
March 12, 2018 GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions…
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Hospitals
Xtant Medical Receives 510k Clearance for Expanded Indications of Irix-A
BELGRADE, Mont., Sept. 12, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of…
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Biologics
Kuros receives clearance for MagnetOs Putty for commercialization in the United States and files the product for CE marking in Europe
Schlieren (Zurich), Switzerland, August 28, 2017 – Kuros Biosciences announced today that it has received 510(k) clearance from the US…
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Spine
K2M First-to-Market with 3D-Printed Corpectomy Cage System Following FDA Clearance of CAPRI™ Small 3D Static Featuring Lamellar 3D Titanium Technology™
LEESBURG, Va., June 28, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader…
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Hospitals
Exactech Receives 510(k) Clearance for Computer-Assisted Shoulder Arthroplasty Technology
GAINESVILLE, Fla.–(BUSINESS WIRE)– May 15, 2017 Exactech, Inc. (EXAC), a developer and producer of bone and joint restoration products and…
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Hospitals
Joimax® Announces 510(k) Clearance for Its Endovapor® 2 Multi Radio Frequency System
April 26, 2017 IRVINE, Calif.–(BUSINESS WIRE)–joimax®, the German based market leader of technologies and training methods for endoscopic minimally invasive…
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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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Financial
FDA raises medical device user fees more than 4%
By Brad Perriello The FDA is raising the user fees medical device makers pay for the safety watchdog to review…
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Hospitals
25 spine devices receive FDA 510(k) clearance in June
By Laura Dyrda The Food and Drug Administration cleared 25 spine devices in June. 1. Captiva Spine SmartLOX Cervical Plate System from Captiva…
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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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Hospitals
Stryker Spine receives FDA clearance for new plating system
Stryker Corporation’s Spine Division recently announced it has received 510(k) clearance from the FDA for the LITe Plate System, an…
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