FDA (510)k Clearance
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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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Extremities
In2Bones Receives FDA 510(k) Clearance for Quantum™ Total Ankle
February 06, 2020 MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announces clearance from the U.S. Food and Drug Administration to market the…
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Regulatory
Cutting Edge Spine Announces FDA 510(K) Clearance of its New HA Enhanced PEEK Interbody System for a Direct Lateral Approach to the Spine, the EVOL®ha-DLIF
WAXHAW, N.C. (PRWEB) JANUARY 09, 2020 Cutting Edge Spine, a leader in the development and commercialization of bioactive spinal solutions, today…
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Extremities
Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Lesser Tarsometatarsal (TMT) Joint Arthrodesis System
WARSAW, IND. (PRWEB) JANUARY 06, 2020 Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity musculoskeletal space,…
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Regulatory
Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision™, the First Augmented Reality Guidance System for Surgery
CHICAGO,12/23/2019– Augmedics, a pioneer in augmented reality surgical image guidance, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance…
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Regulatory
Life Spine Announces FDA 510(k) Clearance of the Titanium Stand-Alone ALIF Spacer System
December 23, 2019 HUNTLEY, Ill,–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Recon
Shoulder Innovations Announces FDA 510(k) Clearance For InSet Plus™ Augmented Glenoids For Total Shoulder System
HOLLAND, Mich., Dec, 10, 2019 /PRNewswire/ — Shoulder Innovations, (SI), a leading innovator in the development of shoulder replacement systems, announced…
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Extremities
OrthoGrid Systems Receives FDA 510(K) Clearance for New PhantomMSK Trauma Application
SALT LAKE CITY, Dec. 10, 2019 /PRNewswire/ — OrthoGrid Systems, Inc., a global medtech leader in alignment technology for orthopedic surgery, announces today…
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Recon
THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology
WASHINGTON, Nov. 21, 2019 /PRNewswire/ — MCRA, LLC (www.mcra.com) is pleased to announce that its client THINK Surgical, Inc. has obtained clearance…
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Regulatory
NuVasive Receives FDA Clearance for Expanded Multi-Level Use of CoRoent Small Interlock™ System for the Cervical Spine
SAN DIEGO, Nov. 21, 2019 /PRNewswire/ –NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine…
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Regulatory
Astura Medical Receives FDA 510(k) Clearance For ALTA Anterior Cervical Corpectomy Spacer System
IRVING, TX – November 13, 2019 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has…
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Regulatory
DiFusion Inc. Announces FDA 510K Clearance for Xiphos™ ZFUZE™
November 04, 2019 AUSTIN, Texas–(BUSINESS WIRE)–DiFusion, Inc. today announced the FDA 510K clearance for the Xiphos-ZF Spinal interbody device. Xiphos-ZF…
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Regulatory
Stryker receives FDA clearance for SAHARA® Lateral 3D Expandable Interbody System
LEESBURG, Virginia, Oct. 31, 2019 /PRNewswire/ — Stryker announced today the U.S. Food and Drug Administration (FDA) 510(k) clearance of its SAHARA Lateral…
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