FDA Product Code
FDA Product Code OWW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Alafair Biosciences | 2025-07-18 | Traditional | PDF ↗ |
| K250021 | Rotium | Nanofiber Solutions, LLC | 2025-02-27 | Traditional | PDF ↗ |
| K242187 | BioBrace® | Conmed Corporation | 2024-11-27 | Traditional | PDF ↗ |
| K241906 | BioBrace® Reinforced Implant | Conmed Corporation | 2024-07-29 | Special | PDF ↗ |
| K240817 | VersaWrap | Alafair Biosciences, Inc. | 2024-06-14 | Traditional | PDF ↗ |
| K222220 | SpinMedix Absorbable Fibrous Membrane | Celestray Biotech Company, LLC., | 2023-07-06 | Traditional | PDF ↗ |
| K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023-05-26 | Traditional | PDF ↗ |
| K203267 | The BioBrace Implant | Biorez, Inc. | 2021-04-30 | Traditional | PDF ↗ |
| K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2016-06-10 | Traditional | PDF ↗ |
| K121216 | STR GRAFT | Soft Tissue Regeneration, Inc. | 2012-11-21 | Traditional | PDF ↗ |
Product code OWW · Class II · General, Plastic Surgery. Data: openFDA.