FDA 510(k)
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Biologics
SINTX Announces Successful FDA 510(k) Pre-Submission Meeting for Silicon Nitride-PEEK Composite Spine Implants
SALT LAKE CITY, Sept. 08, 2022 (GLOBE NEWSWIRE) — SINTX Technologies, Inc. (www.sintx.com) (NASDAQ: SINT) (“SINTX” or the “Company”), an original…
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Spine
Waypoint Orthopedics Submits 510(k) Application for Waypoint GPS™
MALVERN, Pa., July 15, 2022 (GLOBE NEWSWIRE) — Waypoint Orthopedics, Inc., a spinal instrumentation company, announced the company’s recent submission…
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Recon
Episealer® Patellofemoral System – planned 510(k) submission in Q4 2021
FRI, FEB 19, 2021 08:00 CET Episurf Medical (Nasdaq: EPIS B) today announces that the company intends to submit a…
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Regulatory
SpineGuard Files Its “510K” Dossier for the Clearance of Its New “DSG Connect” Platform in the United States
June 4, 2020 PARIS & BOULDER, Colo.–(BUSINESS WIRE)–Regulatory News: SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that deploys its DSG®…
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Regulatory
Life Spine Grows Expandable Portfolio With Secondary FDA 510(k) of the Lateral PROLIFT® Expandable System and 20 New System Launches In 2020
March 03, 2020 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Extremities
TechMah Medical & LimaCorporate Receive First 510k Approval for Smart SPACE Digital Technology
UDINE, Italy, Dec. 9, 2019 /PRNewswire/ — LimaCorporate is pleased to announce the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Smart…
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Biologics
Biogennix Launches Agilon Bone Grafting Solution
September 04, 2019 IRVINE, Calif.–(BUSINESS WIRE)–Irvine-based Biogennix, an osteobiologics company that develops, manufactures, and distributes proprietary bone graft products used for…
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Regulatory
AI for C-Spine Fractures: Aidoc Sets the Pace With 3rd FDA Clearance in 9 Months
TEL AVIV, Israel, June 11, 2019 /PRNewswire/ — Aidoc, the leading provider of AI solutions for radiologists, today announced that the Food and…
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Recon
THINK Surgical Submits to the U.S. FDA for Clearance to Market its Active Robot for use in Total Knee Replacement Procedures
FREMONT, Calif., May 23, 2019 /PRNewswire/ — THINK Surgical, Inc. (“THINK”) announces completion of enrollment for the U.S. investigational clinical study and submission…
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Spine
MEDICREA® Enhances Its Proprietary UNiD ASI™ Service Platform with the Addition of an FDA-Cleared Device Planning and Selection Service
April 18, 2019 LYON & NEW YORK–(BUSINESS WIRE)–The MEDICREA® Group (Euronext Growth Paris: FR0004178572 – ALMED; OTCQX Best Market –…
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Regulatory
FDA Approves First Medical Implant with New Superalloy
ATLANTA, March 27, 2019 /PRNewswire/ — MiRus has received FDA 510(k) approval for the MoRe® based Europa™ Pedicle Screw System making it the…
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Regulatory
SpineEX Receives Additional FDA Clearance for Innovative Sagittae Lateral Lumbar Interbody Fusion System
FREMONT, Calif., March 25, 2019 (GLOBE NEWSWIRE) — SpineEX, Inc., a medical device company focused on the design, development and…
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Hospitals
TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments
October 11, 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
Osseus Fusion Systems’ new family of 3D printed titanium spine implants receives FDA approval
by Sam Davies / 22 August 2018 A Texan medical device company has received FDA approval for five new spinal implants 3D printed in titanium. The…
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Hospitals
Bodycad Receives FDA 510K Clearance for Personalized Unicompartmental Knee System
QUEBEC CITY, March 29, 2017 /PRNewswire/ — Bodycad announced today that it has received U.S. Food and Drug Administration (FDA) 510(k)…
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