fda clearance
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Regulatory
Brainlab Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module for Spine Both Receive FDA clearance
Cirq® Robotic Alignment will be used in combination with Brainlab navigation software for surgical spine procedures. (Source: Brainlab) Opening up…
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Recon
Surgical Planning Associates Receives FDA Clearance for New HipInsight™ Augmented Reality System for Joint Arthroplasty
Dr. Stephen B. Murphy performs the first-ever total hip replacement surgery with an FDA-cleared AR-based surgery system BOSTON, Feb. 10, 2021 /PRNewswire/…
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Regulatory
NGMedical GmbH Receives FDA Clearance for Its AM Titanium Cervical Interbody BEE®
NGMedical achieves milestone with first FDA clearance for its innovative spinal implants. SCOTTSDALE, Ariz., February 3, 2021 (Newswire.com) – NGMedical, a…
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Regulatory
Spinal Elements® Announces FDA Clearance of Lucent® XP-Curved Expandable TLIF Device
January 26, 2021 CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, today announced the FDA clearance of the Lucent® XP-Curved Expandable…
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Extremities
OrthoSpin Ltd. Receives FDA Regulatory Clearance for its G2 System
YOKNEAM, Israel, Jan. 25, 2021 /PRNewswire/ — OrthoSpin Ltd. (“OrthoSpin”), announced today that it received regulatory clearance from the United States Food and Drug…
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Recon
Arthrex Launches First FDA-Cleared ACL Primary Repair Kit
NAPLES, Fla., Dec. 18, 2020 /PRNewswire/ — Arthrex, a global leader in minimally invasive orthopedic technology, announced today the launch of the…
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Regulatory
Medtronic Strengthens Leadership in Navigated, Robotic Spine Surgery with FDA Clearance of Midas Rex™ Drills and Navigated Disc Prep and Interbodies for U.S. with Mazor™ Robotic Guidance System
DUBLIN, Dec. 16, 2020 /PRNewswire/ — Medtronic plc (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) has cleared the use of…
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Extremities
Zebra Medical Vision Secures a 7th FDA Clearance for Its Patented Breakthrough in Orthopedic Surgery Planning
The recently patented medical imaging company’s AI solution extracts exact 3D bone reconstruction from X-ray scans at the same quality…
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Recon
THINK Surgical® Receives FDA Clearance of Second-Generation Active Robot
FREMONT, Calif., Nov. 20, 2020 /PRNewswire/ — THINK Surgical, an innovator in the field of orthopedic active robot surgery, announced today that the…
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Extremities
Nvision Biomedical Technologies: First FDA Clearance for Osteotomy Wedge System Made of PEEK-OPTIMA™ HA Enhanced
THORNTON CLEVELYS, UK – (October 28, 2020) — Nvision Biomedical Technologies, a San Antonio, Texas-based medical device and implant manufacturer,…
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Extremities
FDA Clearance Granted To Wishbone Medical’s Pediatric External Fixation System
WARSAW, Ind., Oct. 13, 2020 (GLOBE NEWSWIRE) — WishBone Medical, Inc., a leader in pediatric orthopedic medical devices, today announced…
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Extremities
FH Ortho Receives FDA Clearance for Telegraph Evolution Humeral Nail System
CHICAGO, Oct. 13, 2020 (GLOBE NEWSWIRE) — FH Ortho Inc, a well-established innovative orthopedic medical device company, is pleased to…
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Extremities
IlluminOss Medical Receives FDA Clearance for Use in Fibula Fractures
EAST PROVIDENCE, R.I., Aug. 18, 2020 /PRNewswire/ — IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced that…
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Extremities
Anika To Launch Six FDA-Cleared Sports Medicine and Extremities Products in Third Quarter of 2020
BEDFORD, Mass., July 20, 2020 (GLOBE NEWSWIRE) — Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated joint preservation, restoration and regenerative solutions…
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Extremities
Paragon 28, Inc. is pleased to announce that the U.S. Food and Drug Administration has cleared the APEX 3D™ Total Ankle Replacement System
ENGLEWOOD, Colo., July 14, 2020 /PRNewswire/ — APEX 3D™ marks the next generation in Total Ankle Arthroplasty, with advanced technologies such as porous…
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