CE Mark
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Regulatory
Bioretec updates its estimate of the timing for approval of the CE mark for the RemeOs™ trauma screw
TAMPERE, Finland, Nov. 4, 2022 /PRNewswire/ — Bioretec Ltd, a pioneer in biodegradable orthopedic implants, expects the European marketing authorization for the RemeOs™…
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Regulatory
Bioretec files for CE mark for its bioresorbable RemeOs magnesium screw in the EU
HELSINKI, Dec. 31, 2021 /PRNewswire/ — Bioretec Ltd, a pioneer in bioresorbable orthopedic implants, has submitted an application for the CE mark…
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Regulatory
Integrity Implants Receives CE Mark for its Novel FlareHawk® Expandable Lumbar Interbody Fusion Device
Spine surgeons throughout the European Union Economic Area (EEA)1 will soon have access to FlareHawk’s minimal insertion profile, multiplanar and endplate-conforming…
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Recon
Vuzix Smart Glasses Expand AR Surgical Product Presence to Support Shoulder, Knee and Spine Surgeries
– NextAR surgical AR platform developed by Medacta International receives CE marking for knee, shoulder and spine applications. – NextAR…
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Regulatory
Spinal Stabilization Technologies Ltd Earns CE Mark, FDA “Breakthrough Designation” For PerQdisc Nucleus Replacement System For Degenerative Disc Disease
KILKENNY, Ireland, May 25, 2021 /PRNewswire/ — Spinal Stabilization Technologies, Ltd. (SST), Kilkenny, Ireland announced today that it has earned the CE Mark and the FDA’s…
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Biologics
Prosidyan® Receives CE Mark for FIBERGRAFT® BG Family of Products
FIBERGRAFT® BG Putty, FIBERGRAFT® BG Putty GPS, FIBERGRAFT® BG Morsels for use in the Lumbar Spine and Anterior Cervical Spine…
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Regulatory
Tsunami Medical announces CE-mark for Second Generation of Spinal Fusion Solutions
Modena, May 17th 2021 Tsunami Medical, one of the leaders in Spine Technology innovation, focusing on additive manufactured solutions for…
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Extremities
EDGe Surgical Receives CE Mark Certification for EDG® Ortho 65mm Electronic Depth Gauge
Enables Access to New EU Markets and Potential to Work with Larger Manufacturers Preparing for EU Medical Device Regulation May…
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Extremities
Orthofix Receives FDA Clearance and CE Mark for the JuniOrtho Plating System
July 20, 2020 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, today…
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Regulatory
7D Surgical Achieves CE Mark Certification for Machine Vision Image Guided Spine Surgery
TORONTO, July 15, 2020 /PRNewswire/ — 7D Surgical announced today that it has achieved CE Mark certification for its innovative Machine-vision Image Guided…
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Recon
CE Marking Renewed into 2024 for IMPLANET MADISON Knee Prosthesis and JAZZ® Spine Ranges
June 9, 2020 BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News: IMPLANET (Euronext Growth : ALIMP, FR0013470168, eligible for PEA-PME equity savings…
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COVID-19
Ortho’s COVID-19 IgG Antibody Test Receives CE Mark
RARITAN, N.J., May 18, 2020 /PRNewswire/ — Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing…
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Recon
Vuzix announces the World’s First Orthopedic Navigation System Using Augmented Reality Smart Glasses developed by Pixee Medical
ROCHESTER, N.Y., May 7, 2020 /PRNewswire/ — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or, the “Company”), a leading supplier of Smart Glasses and Augmented Reality…
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Regulatory
Medacta Announces Several First-time Surgeries and CE Marking for Multiple Products for its Sports Medicine Division
CASTEL SAN PIETRO, 23 January 2020 – Medacta is proud to announce the successful completion of several first-time surgeries in the United…
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Regulatory
Silver Bullet Therapeutics Secures CE Mark Approval for Revolutionary New Antimicrobial Bone Screw System
January 09, 2020 SAN JOSE, Calif.–(BUSINESS WIRE)–Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that it has…
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