fda clearance
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Regulatory
Kuros Biosciences Receives US Marketing Clearance for Intervertebral Body Fusion Device
SCHLIEREN (ZURICH), Switzerland, March 13, 2019 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced that its Dutch subsidiary, Kuros…
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Spine
Introducing The Monaco Pedicle Screw System
West Chester, PA – January 15, 2018 – Altus Spine, a leader in the development and innovation of medical devices…
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Biologics
Lipogems Provides Orthopaedic Patients With Another Option To Major Invasive Surgery
ATLANTA, Jan. 14, 2019 /PRNewswire/ — The Lipogems system is leading the way in reparative medicine by providing patients another option to major,…
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Hospitals
FDA Clears SpinalCyte IND Application for Universal Donor Cell Therapy to Treat Lower Back Pain
November 28, 2018 HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using…
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Hospitals
United Orthopedic Corporation Announces FDA Clearance for Vitamin E Highly Cross-Linked Polyethylene Hip Liner
IRVINE, Calif., Nov. 27, 2018 /PRNewswire/ — United Orthopedic Corporation, a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments,…
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Hospitals
Siemens Healthineers Announces FDA Clearance of Cios Spin Mobile 3D C-Arm
Malvern, PA | Nov 06, 2018 Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Cios Spin, a…
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Hospitals
Stimwave Receives FDA Clearance for World’s Only Opioid Free Pain Management Wireless System iPhone-iWatch Controllers
October 31, 2018 POMPANO BEACH, Fla.–(BUSINESS WIRE)–Stimwave Technologies, the leading innovator of wireless medical device bioelectronic technology, today announced that…
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Hospitals
K2M Receives FDA Clearance Including Surgical Guidance that Enhances MESA® Platform Using Patient-Specific Rods & Rails
LEESBURG, Va., Oct. 10, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex…
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Extremities
AMDT Holdings, Inc. Gains FDA Clearance for the SixFix™ System
COLLIERVILLE, Tenn., Sept. 5, 2018 /PRNewswire/ — AMDT Holdings, Inc. (AMDT) is pleased to announce FDA clearance for their patented SixFix deformity…
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Hospitals
FDA Clears First Nanotechnology Peek Devices for Spinal Intervertebral Fusion
July 17, 2018 NASHUA, N.H.–(BUSINESS WIRE)–Vallum Corporation, a medical device company, today announced that it has received clearance from the…
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