510k
-
Hospitals
Medtronic Announces New Bone Cement Indication for Treating Sacral Fractures
DUBLIN – March 14, 2017 – Medtronic plc (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA)…
Read More » -
Hospitals
DJO Global Announces FDA 510(k) Clearance for Exprt® Revision Hip
March 15, 2017 SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed…
Read More » -
Hospitals
Amend Surgical Announces 510(K) Clearance for NanoFUSE® BA
March 02, 2017 ALACHUA, Fla.–(BUSINESS WIRE)–Amend Surgical, Inc., a medical device company focused on enhancing the regenerative capacity of bone…
Read More » -
Hospitals
7D Surgical Receives FDA 510(K) and Health Canada MDL Clearance for Its Breakthrough Image Guidance System for Spine Surgery
TORONTO, Jan. 23, 2017 /PRNewswire/ — 7D Surgical announced today that it has received both 510(k) clearance from the U.S. Food and…
Read More » -
Hospitals
Camber Spine Technologies Announces 510(k) Clearance For Their Siconus(TM) SI Joint Fixation System
WAYNE, Pa., Jan. 23, 2017 — (Healthcare Sales & Marketing Network) — Camber Spine Technologies, today announced that it has…
Read More » -
Hospitals
Amplitude Surgical Announces That is Has Been Granted Approval to Market Its Anatomic® Total Knee Prosthesis in the United States
January 20, 2017 VALENCE, France–(BUSINESS WIRE)–Regulatory News: Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player…
Read More » -
Hospitals
Precision Spine® Announces 510(k) Clearance of the ShurFit® ACIF 2C System
January 18, 2017 PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has announced today that…
Read More » -
Hospitals
Medicrea Announces 510(k) Submission for FDA Clearance of Proprietary 3D-Printed Titanium Spinal Interbody Devices
January 09, 2017 01:30 AM Eastern Standard Time LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 –…
Read More » -
Hospitals
Precision Spine® Announces 510(k) Clearance of the AccuFit® Lateral Plating System
December 27, 2016 PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc. announced today that it recently received 510(k) clearance of its AccuFit®Lateral Plating…
Read More » -
Hospitals
KYOCERA Medical Corporation Receives FDA 510(k) Clearance for Initia® Total Hip System, Featuring BIOCERAM AZUL® Ceramic Femoral Head
December 05, 2016 SAN DIEGO–(BUSINESS WIRE)–Kyocera Medical Corporation, a leading manufacturer of implantable systems and advanced ceramic components, today announced…
Read More » -
Hospitals
SeaSpine Announces 510(k) Clearance from the FDA of Mariner Posterior Fixation System
CARLSBAD, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation(NASDAQ:SPNE), a global medical technology company focused on surgical solutions…
Read More » -
Hospitals
EOS imaging Receives FDA 510(k) Clearance for kneeEOS 3D Surgical Planning Software for Total Knee Arthroplasty
November 07, 2016 PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today that…
Read More » -
Hospitals
SeaSpine Announces 510(k) Clearance from the FDA of Shoreline ACS System
CARLSBAD, Calif, Oct. 27, 2016 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment…
Read More » -
Hospitals
RTI Surgical® Announces Additional 510(k) Clearance for the Streamline® OCT System
ALACHUA, Fla. (October 26, 2016) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, is pleased to announce…
Read More » -
Hospitals
Spineology Announces FDA Clearance of Rampart™ Duo™ Interbody Fusion System
October 25, 2016 ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology, Inc. the innovator in anatomy-conserving surgery™, is excited to announce FDA clearance of…
Read More »