Panels › General, Plastic Surgery › Product code OWX · Class 2
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Regulation 878.3300
1510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OWX
| Company | 510(k)s | Recalls |
|---|---|---|
| Anika Therapeutics, Inc. | 2 | 0 |
| ZuriMED Technologies AG | 2 | 0 |
| Arthrex, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 2, 2026 | K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit ZuriMED Technologies AG, CH | OWX |
| Jun 17, 2025 | K250997 | Integrity Implant Anika Therapeutics, Inc. | OWX |
| May 29, 2025 | K243480 | SuturePatch Tissue Reinforcement Arthrex, Inc. | OWX |
| Dec 11, 2024 | K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) ZuriMED Technologies AG, CH | OWX |
| Aug 17, 2023 | K223538 | Integrity Implant Anika Therapeutics, Inc. | OWX |
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