OWX — Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon Class II
FDA product code OWX covers "Mesh, Surgical, Non-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 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OWX
- 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 |
|---|---|---|---|
| K253867 | zurimed technologies | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | January 2, 2026 |
| K250997 | anika therapeutics | Integrity Implant | June 17, 2025 |
| K243480 | arthrex | SuturePatch Tissue Reinforcement | May 29, 2025 |
| K241219 | zurimed technologies | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument | December 11, 2024 |
| K223538 | anika therapeutics | Integrity Implant | August 17, 2023 |