OWW — Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon Class II
FDA product code OWW covers "Mesh, Surgical, Absorbable, 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 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OWW
- 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 during tendon repair procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251655 | alafair biosciences | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | July 18, 2025 |
| K250021 | nanofiber solutions | Rotium | February 27, 2025 |
| K242187 | conmed corporation | BioBrace® | November 27, 2024 |
| K241906 | conmed corporation | BioBrace® Reinforced Implant | July 29, 2024 |
| K240817 | alafair biosciences | VersaWrap | June 14, 2024 |
| K222220 | celestray biotech company, llc | SpinMedix Absorbable Fibrous Membrane | July 6, 2023 |
| K230316 | international life sciences | FlexBand; FlexPatch; FlexBand Plus | May 26, 2023 |
| K203267 | biorez | The BioBrace Implant | April 30, 2021 |
| K160364 | alafair biosciences | VersaWrap Tendon Protector | June 10, 2016 |
| K121216 | soft tissue regeneration | STR GRAFT | November 21, 2012 |