FDA Product Code
FDA Product Code OWY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251690 | Arthrex SpeedFLEX Implant | Arthrex, Inc. | 2025-09-30 | Traditional | PDF ↗ |
| K252647 | Tapestry Biointegrative Implant | Embody, Inc. | 2025-09-19 | Special | PDF ↗ |
| K250109 | TYBR Collagen Gel | Tybr Health | 2025-06-06 | Traditional | PDF ↗ |
| K243843 | Tendon Protect (50242) | Kerecis Limited | 2025-06-04 | Traditional | PDF ↗ |
| K242631 | REGENETEN Bioinductive Implant | Smith & Nephew Inc., Endoscopy Div. | 2024-11-26 | Traditional | PDF ↗ |
| K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023-05-11 | Traditional | PDF ↗ |
| K220867 | Tapestry Biointegrative Implant | Embody, Inc. | 2022-05-23 | Traditional | PDF ↗ |
| K212306 | Tapestry Biointegrative Implant | Embody, Inc. | 2021-11-02 | Traditional | PDF ↗ |
| K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020-10-19 | Traditional | PDF ↗ |
| K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016-01-08 | Traditional | PDF ↗ |
| K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | Rotation Medical, Inc. | 2014-03-26 | Traditional | PDF ↗ |
| K133169 | MESO TENDON MATRIX | Kensey Nash Corporation Dba Dsm Biomedical | 2013-12-20 | Traditional | PDF ↗ |
| K131143 | TRELLIS COLLAGEN RIBBON | Wrightmedicaltechnologyinc | 2013-10-07 | Traditional | PDF ↗ |
| K120479 | MTF FASCIA | Musculoskeletal Transplant Foundation | 2012-11-08 | Traditional | PDF ↗ |
Product code OWY · Class II · General, Plastic Surgery. Data: openFDA.