FDA (510)k Clearance
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Regulatory
Zimmer Biomet Receives FDA Clearance of ROSA® ONE Spine System for Robotically-Assisted Surgeries
WARSAW, Ind., March 25, 2019 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced…
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Regulatory
Implanet: FDA Clearance for JAZZ Cap® System
March 19, 2019 BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News: IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity…
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Recon
Exactech to Expand Hip Replacement System with New Acetabular Implant Featuring Vitamin E Technology
March 14, 2019 GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions…
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Extremities
Catalyst OrthoScience Announces 510(k) Clearance for Uncemented Press Fit Humeral Component During the 2019 AAOS Annual Meeting
March 13, 2019 NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, today…
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Recon
OrthoGrid Systems’ PhantomMSK™ Platform Receives FDA 510(k) Clearance for Novel Distortion Adaptation Technology in Orthopedic Surgery
February 26, 2019 OrthoGrid Systems, Inc., a leading innovator in intraoperative surgical imaging, workflow efficiency and decision-making support in orthopedic…
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Regulatory
Alphatec Announces FDA Clearance of its Automated SafeOp Neuromonitoring System to Address Significant Unmet Needs in Spine Surgery
CARLSBAD, Calif., Feb. 25, 2019 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC) announced today that…
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Extremities
NuVasive’s Proprietary Magnetic Implant System To Be Used In First-Of-Its-Kind, All-Internal Bone Transport System
SAN DIEGO, Feb. 19, 2019 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with…
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Recon
Zimmer Biomet Receives FDA Clearance for ROSA® Knee System for Robotically-Assisted Surgeries
WARSAW, Ind., Jan. 25, 2019 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today…
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Extremities
Additive Orthopaedics Announces FDA Clearance of their Patient Specific 3D Printed Locking Lattice Plates for the Global Extremities Market
LITTLE SILVER, N.J., Jan. 14, 2019 /PRNewswire/ — Additive Orthopaedics, LLC., the leader in 3D printed orthopaedic foot and ankle devices, announces…
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Extremities
OSSIO Receives FDA 510(k) Clearance for OSSIOfiber™ Bone Pin Product Family
January 14, 2019 WOBURN, Mass.–(BUSINESS WIRE)–OSSIO, an orthopedic fixation company, today announced that its OSSIOfiber™ BonePin Family has received 510(k)…
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Hospitals
NuVasive Grows Cervical Spinal Interbody Portfolio With PEEK Corpectomy Implant
SAN DIEGO, Dec. 10, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally…
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Spine
Nexxt Spine Launches SAXXONY® Posterior Cervical Thoracic Spine System
December 04, 2018 NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal…
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Hospitals
Astura Medical Receives FDA 510(k) Clearance For OLYMPIC MIS Posterior Spinal Fixation System
CARLSBAD, CA – November 26, 2018 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has…
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Hospitals
OrthoXel™ Orthopaedic Trauma Device Company Announce CE Mark Clearance Following FDA 510(k) for new Apex Femoral Nailing System
CORK, Ireland, Nov. 20, 2018 /PRNewswire/ — OrthoXel is a specialist orthopaedic trauma company, using innovative engineering design to evolve truly next generation…
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Hospitals
NuVasive’s Proprietary Porous PEEK™ Implant To Be Used In Flagship XLIF® Procedure
SAN DIEGO, Nov. 8, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with…
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