FDA (510)k Clearance
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Hospitals
Shoulder Innovations Announces FDA 510(k) Clearance For Shoulder Technology
HOLLAND, Mich., Nov. 5, 2018 /PRNewswire/ — Shoulder Innovations announced today that they have received FDA clearance for their InSet Humeral Short Stem System. …
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Hospitals
OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Small Stature Scoliosis System with 26th Surgical System
WARSAW, Ind., Oct. 19, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric…
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Hospitals
Centric Medical™ Announces 510(k) Clearance of the SATURN™ External Fixation System
October 18, 2018 HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine®, Inc., which focuses on developing surgical implants for…
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Hospitals
VISEON, Inc. Announces FDA Clearance of the Voyant System for Minimally Invasive Spine Surgery Access, Visualization, and Illumination
October 18, 2018 IRVINE, Calif.–(BUSINESS WIRE)–Viseon, Inc. today announced that it has received 510(k) clearance from the U.S. Food and…
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Hospitals
SpineEX® Announces FDA Clearance of Sagittae® Lateral Lumbar Interbody Fusion Devices
FREMONT, Calif., Oct. 10, 2018 /PRNewswire/ — SpineEX, Inc., a medical device company that aims to provide innovative and minimally invasive implants,…
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Hospitals
Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology 3D-Printed Lateral Interbody Fusion System
REDLANDS, Calif. and AUSTIN, Texas, Sept. 26, 2018 /PRNewswire/ — Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food…
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Hospitals
Stryker announces 510(k) clearance of SpineJack® Implantable Fracture Reduction System
KALAMAZOO, Michigan, USA, Sept. 26, 2018 /PRNewswire/ — Stryker announced today that it has received FDA 510(k) clearance to market the SpineJack Implantable…
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Hospitals
Alphatec Advances Clinical Distinction With OsseoScrew® Clearance
CARLSBAD, Calif., Sept. 26, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC), a provider of…
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Spine
Captiva Spine Adds TirboLOX-C Titanium Cervical Cage to 3D Printed Dual Layer Lattice Structure Offering
September 20, 2018/by Captiva Spine Jupiter, FL – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to…
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Hospitals
Synergy Biomedical Announces FDA Clearance of BIOSPHERE® FLEX
September 25, 2018 COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received…
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Biologics
Synergy Biomedical Announces Launch of BIOSPHERE MIS PUTTY
September 21, 2018 COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received…
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Hospitals
b-ONE Ortho Receives U.S. FDA 510(k) Clearance for Total Hip System
September 21, 2018 CEDAR KNOLLS, N.J.–(BUSINESS WIRE)–b-ONE Ortho Corp., an emerging orthopedic technology company dedicated to the development of innovative…
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Hospitals
CoreLink Surgical, LLC, Today Announced 510(k) Clearance to Market the M3™ Stand-Alone Anterior Lumbar (ALIF) System
September 11, 2018 ST. LOUIS–(BUSINESS WIRE)–CoreLink Surgical, LLC, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA)…
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Hospitals
Captiva Spine Announces TowerLOX-EXT® MIS Extended Tab Pedicle Screw Receives Clearance
Jupiter, FL, September 2018 – Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine fusion solutions announced…
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Hospitals
Captiva Spines’s TirboLOX-L™ Dual Layer Organic Lattice Structure 3D Printed Titanium Lumbar Cages Receive Clearance
Jupiter, FL, August 2018 – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart,…
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