OWY — Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon Class II
FDA product code OWY covers "Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 14 recent 510(k) clearances have been granted under this product code.
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 |