FDA (510)k Clearance
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Recon
Onkos Surgical Receives FDA 510(k) Clearance for 3D Printed, Patient-Specific Pelvic Reconstruction System
Company expands its portfolio of musculoskeletal oncology and complex orthopaedic solutions to include conditions of the pelvis PARSIPPANY, N.J., July 14,…
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Regulatory
Accelus Receives U.S. FDA 510(k) Clearance for its FlareHawk TiHawk11 Interbody Fusion System
PALM BEACH GARDENS, Fla., May 12, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical technology company focused on accelerating…
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Extremities
Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Subtalar Joint Fusion System
InCore line of products expands with latest addition. WARSAW, IND. (PRWEB) JANUARY 14, 2022 Nextremity Solutions, Inc., a strategic commercialization organization…
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Regulatory
New View Surgical, Inc. Announces FDA Clearance of its VisionPort™ System for Minimally Invasive Surgery
The VisionPort™ is the first surgeon-controlled, multi-camera laparoscopic visualization system June 23, 2021 BOSTON–(BUSINESS WIRE)–New View Surgical, Inc., a medical…
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Regulatory
Inspired Spine announces Trident™ SI Joint Screw System Secures FDA 510(k) Approval
BURNSVILLE, Minn., Jan. 26, 2021 /PRNewswire/ — Inspired Spine has announced the Trident SI Joint Screw System, manufactured by Advanced Research Medical (ARM),…
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Spine
Nexxt Spine Rolls Out Corpectomy System to Surgeons
Top manufacturer of spinal solutions unleashes anticipated 3D printed titanium corpectomy cage to the market March 31, 2020- Noblesville, IN-…
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Extremities
Gramercy Extremity Orthopedics® Receives FDA 510(k) Clearance for GEO FirstFuse MTPJ Fusion Plating System
RICHARDSON, TEXAS, UNITED STATES, March 30, 2020 /EINPresswire.com/ — Gramercy Extremity Orthopedics® (GEO) today announced it has received the U.S. Food…
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Regulatory
OrthoPediatrics Corp. Receives FDA 510(k) Clearance and Expanded Neuromuscular Indications for its RESPONSE™ Scoliosis System
WARSAW, Ind., March 31, 2020 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of…
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Extremities
New KinematX Total Wrist Arthroplasty from Extremity Medical
March 26, 2020 PARSIPPANY, N.J.–(BUSINESS WIRE)–Extremity Medical, a global medical device company with expertise in innovative implants for upper and…
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Extremities
OSSIO Receives FDA 510(k) Clearance for OSSIOfiber® Hammertoe Fixation System
March 12, 2020 WOBURN, Mass.–(BUSINESS WIRE)–OSSIO, Inc., an orthopedic fixation company, today announced that its OSSIOfiber® Hammertoe Fixation System has…
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Regulatory
CoNextions Inc. Announces FDA 510(k) Clearance of Coronet™ System, a Revolutionary Tenodesis Product
SALT LAKE CITY, March 12, 2020 /PRNewswire/ — CoNextions Inc. (www.conextionsmed.com) announced today that it received a 510(k) clearance (K200028) from the…
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Biologics
Biogennix Receives FDA Clearance for Expanded Use of Agilon Moldable Bone Grafting Solution in Spine Procedures
March 04, 2020 IRVINE, Calif.–(BUSINESS WIRE)–Irvine-based Biogennix, an osteobiologics company that develops, manufactures, and distributes proprietary bone graft products used for…
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Extremities
Paragon 28® Phantom® ActivCore Nail System Receives 510(k) Clearance – Continuous Compression Hindfoot Nail System
ENGLEWOOD, Colo., Feb. 7, 2020 /PRNewswire/ — The Phantom® ActivCore Nail addresses TTC arthrodesis and is the second of three hindfoot fusion nailing systems…
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Extremities
Paratrooper™ Plantar Plate System Receives 510(k) Clearance – 1st Dedicated System Allowing Surgeons to Repair the Plantar Plate Through Either a Dorsal or Plantar Approach
ENGLEWOOD, Colo., Feb. 7, 2020 /PRNewswire/ — The Paratrooper™ Plantar Plate Repair System was developed to allow surgeons to use a dorsal…
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Regulatory
Life Spine Announces FDA 510(k) of the Steerable PLATEAU® Ti System
February 06, 2020 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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