OWX
5 FDA 510(k) clearances · Product code
202 daysmedian time to decision
267 days90th percentile
5clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- For reinforcement of soft tissue where weakness exists in tendon repair.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (K253867) | ZuriMED Technologies AG | 2026-01-02 |
| Integrity™ Implant (K250997) | Anika Therapeutics, Inc. | 2025-06-17 |
| SuturePatch Tissue Reinforcement (K243480) | Arthrex, Inc. | 2025-05-29 |
| FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (K241219) | ZuriMED Technologies AG | 2024-12-11 |
| Integrity Implant (K223538) | Anika Therapeutics, Inc. | 2023-08-17 |
Track OWX automatically
Every clearance here is in the API, with alerts when new ones post.