Panels › General, Plastic Surgery › Product code OWY · Class 2
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation 878.3300
0510(k)s in 12 months (14 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OWY
| Company | 510(k)s | Recalls |
|---|---|---|
| Embody, Inc. | 4 | 0 |
| Arthrex, Inc. | 1 | 0 |
| Fibralign Corporation | 1 | 0 |
| Kensey Nash Corporation Dba Dsm Biomedical | 1 | 0 |
| Kerecis Limited | 1 | 0 |
| Musculoskeletal Transplant Foundation | 1 | 0 |
| Rotation Medical, Inc. | 1 | 0 |
| Smith and Nephew, Inc. | 1 | 0 |
| Smith & Nephew Inc., Endoscopy Div. | 1 | 0 |
| Tybr Health | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2025 | K251690 | Arthrex SpeedFLEX Implant Arthrex, Inc. | OWY |
| Sep 19, 2025 | K252647 | Tapestry Biointegrative Implant Embody, Inc. | OWY |
| Jun 6, 2025 | K250109 | TYBR Collagen Gel Tybr Health | OWY |
| Jun 4, 2025 | K243843 | Tendon Protect (50242) Kerecis Limited, IS | OWY |
| Nov 26, 2024 | K242631 | REGENETEN Bioinductive Implant Smith & Nephew Inc., Endoscopy Div. | OWY |
| May 11, 2023 | K222501 | Regeneten Bioinductive Implant Smith and Nephew, Inc. | OWY |
| May 23, 2022 | K220867 | Tapestry Biointegrative Implant Embody, Inc. | OWY |
| Nov 2, 2021 | K212306 | Tapestry Biointegrative Implant Embody, Inc. | OWY |
| Oct 19, 2020 | K201572 | TAPESTRY Biointegrative Implant Embody, Inc. | OWY |
| Jan 8, 2016 | K151083 | BioBridge Collagen Matrix Fibralign Corporation | OWY |
| Mar 26, 2014 | K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) Rotation Medical, Inc. | OWY |
| Dec 20, 2013 | K133169 | MESO TENDON MATRIX Kensey Nash Corporation Dba Dsm Biomedical | OWY |
| Oct 7, 2013 | K131143 | TRELLIS COLLAGEN RIBBON Wrightmedicaltechnologyinc | OWY |
| Nov 8, 2012 | K120479 | MTF FASCIA Musculoskeletal Transplant Foundation | OWY |
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