fda clearance
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Extremities
CrossRoads® Extremity Systems, LLC Announces Launch of the HiMax® Plus Widebody™ Fixation System for Foot Fusions
MEMPHIS, Tenn., Feb. 18, 2020 /PRNewswire/ — CrossRoads® Extremity Systems, the global leader in Staple Compression Plates(SCP) and nitinol technology for the lower extremities, announced…
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Regulatory
Additive Implants Announces FDA Clearance for SureMAX™-X Cervical Spacer
PHOENIX, Feb. 18, 2020 /PRNewswire/ — Additive Implants, Inc. is pleased to announce it received regulatory clearance to market in the US its…
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Regulatory
MEDICREA® Announces FDA Clearance of the World’s First Patient-Matched Spinal Interbody Cages
February 11, 2020 LYON, France & NEW YORK–(BUSINESS WIRE)–MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX :…
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Recon
Conformis Announces FDA Clearance and Full Commercial Launch of Next Generation Hip System at the 2019 AAHKS Conference
BILLERICA, Mass., Nov. 07, 2019 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant…
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Regulatory
Medacta Announces First U.S. Surgery with MectaScrew PEEK following FDA Clearance
CASTEL SAN PIETRO, 4 November 2019 – Medacta is proud to announce the successful completion of the first U.S. surgery utilizing its…
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Regulatory
CarboFix Extends Its CarboClear® Carbon Fiber Spinal Product Line With Its FDA Cleared Vertebral Body Replacement (VBR) System
DOVER, Delaware, Oct. 17, 2019 /PRNewswire/ — CarboFix has announced today that the U.S. Food and Drug Administration (FDA) has cleared its…
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Spine
DeGen Medical Receives Clearance of Cyclops™ Anterior Cervical Plate System
Florence, SC, Sept. 26, 2019 (GLOBE NEWSWIRE) — DeGen Medical has received clearance from the FDA for its cervical spine implant, Cyclops™ Anterior Cervical Plate System.…
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Regulatory
Viseon, Inc. Announces US FDA Clearance and Clinical Use of its Advanced High-Definition Real Time Imaging Technology for Minimally Invasive Spine Surgery
September 19, 2019 IRVINE, Calif.–(BUSINESS WIRE)–Viseon, Inc. today announced US FDA clearance and initial clinical use of their Voyant System,…
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Extremities
OrthoSpin Receives FDA Regulatory Clearance
MISGAV, Israel, Sept. 18, 2019 /PRNewswire/ — OrthoSpin Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) (SGX: 42T) (OTCQX: TRNLY), announced today that it…
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Extremities
Arthrosurface Receives FDA Clearance for BOSS™ Toe Fixation System
FRANKLIN, Mass., Sept. 5, 2019 /PRNewswire/ — Arthrosurface®, Inc., a global leader in joint preservation technology, recently received 501K clearance from the FDA for…
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Neuro
SurGenTec® Announces FDA Clearance for Neurostimulation with ALARA™ Access Needle Kit
August 22, 2019 BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec, a privately held spine and orthopedic technology company, announced today it has received…
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Regulatory
MEDICREA® Announces FDA Clearance of TULIP GENESIS to Complete its UNiDTM ASI platform technology
August 02, 2019 LYON, France & NEW YORK–(BUSINESS WIRE)–The MEDICREA® Group (Euronext Growth Paris: FR0004178572 – ALMED ; OTCQX Best…
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Regulatory
Artoss, Inc. Announces FDA Clearance of NanoBone® SBX Putty for Standalone Use in Posterolateral Spinal Fusion
April 24, 2019 Artoss, Inc. is pleased to announce that the US Food & Drug Administration has cleared NanoBone SBX…
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