FDA Product Code
FDA Product Code OWX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG | 2026-01-02 | Special | PDF ↗ |
| K250997 | Integrity Implant | Anika Therapeutics, Inc. | 2025-06-17 | Traditional | PDF ↗ |
| K243480 | SuturePatch Tissue Reinforcement | Arthrex, Inc. | 2025-05-29 | Traditional | PDF ↗ |
| K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) | ZuriMED Technologies AG | 2024-12-11 | Traditional | PDF ↗ |
| K223538 | Integrity Implant | Anika Therapeutics, Inc. | 2023-08-17 | Traditional | PDF ↗ |
Product code OWX · Class II · General, Plastic Surgery. Data: openFDA.