CE Mark
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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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Hospitals
TransEnterix Receives CE Mark Approval for Senhance Ultrasonic Instrument System
October 01, 2018 RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface…
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Hospitals
SpineVision® Receives CE Mark for Next-Gen P.L.U.S.® Deformity-Correction Spinal System
ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received CE mark for its next-generation Pivot Link Universal System (P.L.U.S.) spine deformity-correction system. SpineVision will introduce…
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Hospitals
SpineVision® Receives FDA Clearance and CE Mark for Next-Gen Titanium 3D-Printed HEXANIUM TLIF Cage
September 17, 2018 ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received FDA clearance and CE mark for its next-generation titanium 3D laser-printed HEXANIUM TLIF (Transforaminal Lumbar…
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Spine
EIT Emerging Implant Technologies Announces CE Mark and First Cases for the World’s First Fully 3D Printed Adjustable Cage.
Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by…
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Hospitals
Synergy Biomedical Receives CE Mark for BIOSPHERE PUTTY
February 28, 2017 COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery,…
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Hospitals
Medovex Corporation Completes Phase II CE Mark Audit with Notified Body LNE/GMED
ATLANTA, GA–(Marketwired – Feb 15, 2017) – Medovex Corp. ( NASDAQ : MDVX ), a developer of medical technology products,…
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Hospitals
Brexit and the CE Mark – implications for European regulation of medical devices
Arthur Brandwood – June 26, 2016 The questions are coming thick and fast about the implications of the UK’s decision…
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Extremities
Anika Therapeutics Wins CE Mark Approval for Cingal® for the Treatment of Pain Associated with Osteoarthritis of the Knee
BEDFORD, Mass.–(BUSINESS WIRE)– Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its…
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Spine
Xtant™ Medical Receives CE Mark for Its Aranax™ Cervical Plating System and Irix-A™ Stand Alone Anterior Lumbar Interbody Fusion Device
BELGRADE, Mont., March 03, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of…
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Spine
K2M Receives CE Mark for Its Next-Generation RHINE(TM) Cervical Disc System
LEESBURG, Va., Jan. 21, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on…
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Spine
Xtant™ Medical Announces the Global Launch for the Certex® OCT Spinal Fixation System
BELGRADE, Mont., Dec. 08, 2015 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE:XTNT), a leader in the development of regenerative…
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Extremities
Moximed Announces CE Mark and First Commercial Use of AtlasTM Knee System
HAYWARD, Calif.–(BUSINESS WIRE)–Moximed®, Inc. announced the CE Mark of the Atlas Knee System, its next-generation knee joint unloader for pre-arthroplasty…
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Spine
Innov’spine’s CE mark for spinal rods from Invibio´s PEEK-OPTIMA polymer
Thornton Cleveleys, United Kingdom – Polymeric spinal rods provide a bridge between rigid all-metal spinal implants and more dynamic therapeutic…
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Hospitals
GRAFTYS Announces the Extension of its CE Mark for Its Calcium Phosphate Cements to Now Include GRAFTYS® HBS and GRAFTYS® Quickset for the Indication of Subchondral Bone Marrow Lesions around the Knee Joint (BML)
GRAFTYS SA, a company focused on development and commercialization of orthopedic biomaterials, is pleased to announce that it has obtained…
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