Product code OWY
- Device name
- Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For reinforcement of soft tissue where weakness exists in tendon repair.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251690 | Arthrex SpeedFLEX™ Implant | Arthrex, Inc. | 2025-09-30 |
| K252647 | Tapestry Biointegrative Implant | Embody, Inc. | 2025-09-19 |
| K250109 | TYBR Collagen Gel | Tybr Health | 2025-06-06 |
| K243843 | Tendon Protect (50242) | Kerecis Limited | 2025-06-04 |
| K242631 | REGENETEN™ Bioinductive Implant | Smith & Nephew Inc., Endoscopy Div. | 2024-11-26 |
| K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023-05-11 |
| K220867 | Tapestry Biointegrative Implant | Embody, Inc. | 2022-05-23 |
| K212306 | Tapestry Biointegrative Implant | Embody, Inc. | 2021-11-02 |
| K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020-10-19 |
| K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016-01-08 |
| K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | Rotation Medical, Inc. | 2014-03-26 |
| K133169 | MESO TENDON MATRIX | Kensey Nash Corporation Dba Dsm Biomedical | 2013-12-20 |
| K131143 | TRELLIS COLLAGEN RIBBON | Wrightmedicaltechnologyinc | 2013-10-07 |
| K120479 | MTF FASCIA | Musculoskeletal Transplant Foundation | 2012-11-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812337020794 | Meso Tendon Matrix | DSM BIOMEDICAL, INC. | 2026-03-24 |
| 00812337020800 | Meso Tendon Matrix | DSM BIOMEDICAL, INC. | 2026-03-24 |
| 00812337020695 | Medeor Tendon Matrix | DSM BIOMEDICAL, INC. | 2026-03-24 |
| 00812337020701 | Medeor Tendon Matrix | DSM BIOMEDICAL, INC. | 2026-03-24 |
| 00812337020824 | Meso Tendon Matrix | DSM BIOMEDICAL, INC. | 2026-03-24 |
| 00812337020817 | Meso Tendon Matrix | DSM BIOMEDICAL, INC. | 2026-03-24 |
| 05694310966443 | Kerecis SurgiBind® Tendon Protect | KERECIS hf. | 2026-02-03 |
| 05694310966474 | Kerecis SurgiBind® Tendon Protect | KERECIS hf. | 2026-02-03 |
| 00888867543133 | Arthrex® | ARTHREX, INC. | 2025-12-01 |
| 00888867395091 | Arthrex® | ARTHREX, INC. | 2025-12-01 |
| 00888867395084 | Arthrex® | ARTHREX, INC. | 2025-12-01 |
| 00888867543140 | Arthrex® | ARTHREX, INC. | 2025-12-01 |
| 10653405990154 | BioBrace | Conmed Corporation | 2024-09-20 |
| 10653405990147 | BioBrace | Conmed Corporation | 2024-09-20 |
| 10653405990130 | BioBrace | Conmed Corporation | 2024-09-20 |
| 10653405990123 | BioBrace | Conmed Corporation | 2024-09-20 |
| 10653405988939 | BioBrace | Conmed Corporation | 2024-02-12 |
| 10653405988960 | BioBrace | Conmed Corporation | 2024-02-12 |
| 10653405988953 | BioBrace | Conmed Corporation | 2024-02-12 |
| 10653405988946 | BioBrace | Conmed Corporation | 2024-02-12 |
| 00860006566715 | BioBrace 23mm | Biorez, Inc. | 2021-05-24 |
| 00860006566708 | BioBrace 5mm | Biorez, Inc. | 2021-05-24 |
| 00810063820015 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020-11-20 |
| 00810063820022 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020-11-20 |
| 00885556735664 | Bioinductive Implant with Arthroscopic Delivery System - Large | Smith & Nephew, Inc. | 2019-08-20 |
| 00885556735657 | Bioinductive Implant with Arthroscopic Delivery System - Medium | Smith & Nephew, Inc. | 2019-08-20 |
| 00854501006036 | Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Large | Smith & Nephew, Inc. | 2015-10-23 |
| 00854501006029 | Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Medium | Smith & Nephew, Inc. | 2015-10-23 |
| 00854501006012 | Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Large | Smith & Nephew, Inc. | 2015-10-23 |
| 00854501006005 | Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium | Smith & Nephew, Inc. | 2015-10-23 |