FDA (510)k Clearance
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Hospitals
K2M Receives FDA Clearance for BACS® Patient-Specific Module
LEESBURG, Va., May 30, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex…
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Hospitals
Providence Medical Technology Announces FDA 510(k) Clearance for DTRAX® Spinal System
PLEASANTON, Calif., May 22, 2018 /PRNewswire/ — Providence Medical Technology, Inc., a manufacturer of innovative instruments and implants for cervical fusion surgery, today…
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Hospitals
Xtant Medical Receives FDA 510(K) Clearance for InTice(TM)-C Porous Titanium Cervical Interbody System
BELGRADE, MT / ACCESSWIRE / May 21, 2018 / Xtant Medical Holdings, Inc. (NYSE American: XTNT), a leader in the development…
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Hospitals
OrthoPediatrics Corp. Announces FDA 510(k) Clearance for its 25th Surgical System, Pediatric Nailing Platform |FEMUR
WARSAW, Ind., May 14, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of…
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Hospitals
Meditech Spine expands its lumbar plating options by adding the CURE LP iView and QMax to its growing portfolio of spinal implants
ATLANTA, April 30, 2018 /PRNewswire/ — Meditech Spine, LLC, announced today it has received additional 510(k) clearance for its CURE Lumbar Plating…
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Hospitals
Orthofix Receives FDA 510(k) Clearance of G-Beam Fusion Beaming System
March 22, 2018 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and…
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Hospitals
Exactech’s Vitamin E Acetabular Polyethylene Liner for Hip Replacement Gains FDA 510(k) Clearance
March 20, 2018 GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of bone and joint restoration products and biologic solutions for…
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Hospitals
Omnia Medical: First PEEK-OPTIMA™ HA Enhanced Vertebral Body Replacement System to Enter US Market
THORNTON CLEVELEYS, UK (PRWEB) DECEMBER 07, 2017 ‘Omnia Medical VBR’ has been granted the first US FDA 510(k) clearance for a…
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Biologics
SeaSpine Announces FDA 510(k) Clearance of OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh
CARLSBAD, Calif., Nov. 30, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical…
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Hospitals
MedShape Announces FDA Clearance for the DynaNail® XL
ATLANTA, Nov. 14, 2017 /PRNewswire/ — MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company…
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Extremities
IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System
LOGAN, Utah, November 1, 2017 – IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes…
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Extremities
Mortise Medical Receives FDA Clearance for SyndesMetrics Syndesmosis Repair System
LOGAN, Utah, November 14, 2017 – Mortise Medical, a start-up medical device company focused on advanced soft tissue repair systems…
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Extremities
DT MedTech Announces 510(k) FDA Clearance for Hintermann Series H2™ Total Ankle Replacement System
BALTIMORE, Nov. 8, 2017 /PRNewswire/ — DT MedTech, LLC (DTM) today announced that the Hintermann Series H2™ Total Ankle Replacement System has received 510(k)…
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Hospitals
IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System
LOGAN, Utah, Nov. 1, 2017 /PRNewswire/ — IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic…
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Spine
Atlas Spine, Inc., Announces FDA 510(k) Clearance on Ortus Expandable Posterior Lumbar Interbody System
Jupiter, Florida., October 31, 2017 (PR NEWSWIRE) — Atlas Spine, Inc., a high technology, spinal implant and instrumentation company based…
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