FDA 510(k) Applications for Medical Device Product Code "OWY"

FDA 510(k) Number Applicant Device Name Decision Date
K220867 Embody, Inc. Tapestry Biointegrative Implant 05/23/2022
K201572 Embody, Inc. TAPESTRY Biointegrative Implant 10/19/2020
K212306 Embody, Inc. Tapestry Biointegrative Implant 11/02/2021
K151083 Fibralign Corporation BioBridge Collagen Matrix 01/08/2016
K133169 KENSEY NASH CORPORATION DBA DSM BIOMEDICAL MESO TENDON MATRIX 12/20/2013
K243843 Kerecis Limited Tendon Protect (50242) 06/04/2025
K120479 MUSCULOSKELETAL TRANSPLANT FOUNDATION MTF FASCIA 11/08/2012
K140300 ROTATION MEDICAL, INC. COLLAGEN TENDON SHEET-DDI (CTS-DDI) 03/26/2014
K242631 Smith & Nephew Inc., Endoscopy Div. REGENETENÖ Bioinductive Implant 11/26/2024
K222501 Smith and Nephew Inc Regeneten Bioinductive Implant 05/11/2023
K250109 TYBR Health TYBR Collagen Gel 06/06/2025
K131143 WRIGHT MEDICAL TECHNOLOGY, INC. TRELLIS COLLAGEN RIBBON 10/07/2013


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