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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
K120479
MUSCULOSKELETAL TRANSPLANT FOUNDATION
MTF FASCIA
11/08/2012
K140300
ROTATION MEDICAL, INC.
COLLAGEN TENDON SHEET-DDI (CTS-DDI)
03/26/2014
K222501
Smith and Nephew Inc
Regeneten Bioinductive Implant
05/11/2023
K131143
WRIGHT MEDICAL TECHNOLOGY, INC.
TRELLIS COLLAGEN RIBBON
10/07/2013
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