FDA (510)k Clearance
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Hospitals
FDA Grants Eden Spine 510(K) Clearance for Its Thoraco Lumbar Spine Locking Plate – SPHYNX™
GENEVA, SWITZERLAND (PRWEB) AUGUST 30, 2018 The SPHYNX™ is the ideal complement to Eden Spine proprietary, expandable titanium vertebral body replacement…
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Hospitals
Ceterix Orthopaedics Announces FDA Clearance of New Suture Cartridge, Providing Increased Flexibility and Enhanced Options for Surgeons
August 28, 2018 FREMONT, Calif.–(BUSINESS WIRE)–Ceterix® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today…
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Hospitals
CoreLink, LLC Announces 510(k) Clearance for Foundation™ 3D Anterior Lumbar (ALIF)
August 16, 2018 ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a vertically integrated manufacturer of spinal implant systems, today announced 510(k) clearance from…
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Hospitals
NuVasive Unveils Spine’s First Integrated Surgical Automation Platform
SAN DIEGO, July 27, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally…
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Spine
Zavation Announces 510(k) Clearance of the Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage)
FLOWOOD, Miss., July 17, 2018 /PRNewswire/ — Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced today…
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Hospitals
Acron Medical Announces FDA 510(k) Clearance of its Signature PEEK TLIF Interbody System, the ACRON Interbody
ORLANDO (PRWEB) JULY 16, 2018 Acron Medical, LLC (http://www.Acron-Medical.com), part of the spineMED Group, is a spine technology organization, dedicated to…
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Hospitals
Cutting Edge Spine Announces FDA 510(K) Clearance of its New HA Enhanced PEEK Interbody for the Cervical Spine, the EVOL ha-C
WAXHAW, N.C. (PRWEB) JULY 11, 2018 Cutting Edge Spine (http://www.CuttingEdgeSpine.com), a US leader in the development and commercialization of bio-active technologies…
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Hospitals
Arthrosurface receives FDA Clearance of Patellofemoral WaveKahuna Arthroplasty System
FRANKLIN, Mass., June 29, 2018 /PRNewswire/ — Today, Arthrosurface, Inc., a leading provider of minimally invasive, motion preserving joint restoration systems, announces their…
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Hospitals
Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology™ Hyperlordotic ALIF Interbody Spinal Fusion System
REDLANDS, Calif. and AUSTIN, Texas, June 28, 2018 /PRNewswire/ — Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S.…
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Hospitals
icotec AG Received FDA Clearance to Market BlackArmor® Carbon/PEEK Interbody Cages
ALTSTAETTEN, Switzerland, June 12, 2018 /PRNewswire/ — icotec AG, a Swiss company, today announced that its latest line of interbody cages, designed to…
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Hospitals
Centinel Spine Announces 510(k) Clearance of FLX™ Platform of 3D Printed All-Titanium Interbodies
NEW YORK, June 7, 2018 /PRNewswire/ — Centinel Spine, LLC is pleased to announce that it has received 510(k) clearance from the U.S.…
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Hospitals
Diamond Orthopedic Announces 510(k) Clearance for Sterile Faceted Screw Technology
CHARLOTTE, N.C. (PRWEB) JUNE 05, 2018 Diamond Orthopedic announced today that it has received FDA 510k clearance for sterile packaged faceted bone…
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Hospitals
Astura Medical Receives FDA 510(k) Clearance For Cervical and Lumbar HA PEEK Interbody Systems
CARLSBAD, CA – June 4, 2018 – Astura Medical, a high growth, innovative spine technology company, today announced that it received…
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Hospitals
Camber Spine Announces 510(k) Approval Of ENZA™-A Titanium ALIF
WAYNE, Pa., June 4, 2018 /PRNewswire/ — Camber Spine today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration…
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Hospitals
Medicrea Receives World’s First and Only FDA-Clearance to Market Patient-Specific Cages
May 31, 2018 LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea® Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of…
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