OWX
- Product code
- OWX
- Device name
- Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 5
FDA classification definition
For reinforcement of soft tissue where weakness exists in tendon repair.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253867 | 2026-01-02 | ZuriMED Technologies AG | FiberLocker Implant ; FiberLocker Instrument ; Fiber | |
| K250997 | 2025-06-17 | Anika Therapeutics, Inc. | Integrity Implant | |
| K243480 | 2025-05-29 | Arthrex, Inc. | SuturePatch Tissue Reinforcement | |
| K241219 | 2024-12-11 | ZuriMED Technologies AG | FiberLocker System: FiberLocker Implant (SpeedPatch |
Official FDA classification page: OWX
Classification and pathway per current FDA publications. Data from openFDA (CC0).