OWY — Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon Class II
Classification Details
- Product Code
- OWY
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For reinforcement of soft tissue where weakness exists in tendon repair.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251690 | arthrex | Arthrex SpeedFLEX Implant | September 30, 2025 |
| K252647 | embody | Tapestry Biointegrative Implant | September 19, 2025 |
| K250109 | tybr health | TYBR Collagen Gel | June 6, 2025 |
| K243843 | kerecis limited | Tendon Protect (50242) | June 4, 2025 |
| K242631 | smith and nephew inc., endoscopy div | REGENETEN Bioinductive Implant | November 26, 2024 |
| K222501 | smith and nephew | Regeneten Bioinductive Implant | May 11, 2023 |
| K220867 | embody | Tapestry Biointegrative Implant | May 23, 2022 |
| K212306 | embody | Tapestry Biointegrative Implant | November 2, 2021 |
| K201572 | embody | TAPESTRY Biointegrative Implant | October 19, 2020 |
| K151083 | fibralign corporation | BioBridge Collagen Matrix | January 8, 2016 |
| K140300 | rotation medical | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | March 26, 2014 |
| K133169 | kensey nash corporation dba dsm biomedical | MESO TENDON MATRIX | December 20, 2013 |
| K131143 | wrightmedicaltechnologyinc | TRELLIS COLLAGEN RIBBON | October 7, 2013 |
| K120479 | musculoskeletal transplant foundation | MTF FASCIA | November 8, 2012 |