510(k) K253867
- Device
- FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
- Applicant
- ZuriMED Technologies AG
- 510(k) number
- K253867
- Product code
- OWX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-02
- Date received
- 2025-12-03
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Elias Bachmann
- Address
- Lengghalde 5 Zurich CH 8008 8008
FDA Registration Numbers#
- 3015231789
- 3002807315
- 3007093114
- 3006017180
- 3007109793
- 1220477
- 3008793310
- 3034932459
- 1220246
- 3007663067
- 3032412536
- 3010331645
- 3006946276
- 8044102
Source Documents#
Other 510(k) Records For Product Code OWX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250997 | Integrity™ Implant | Anika Therapeutics, Inc. | 2025-06-17 |
| K243480 | SuturePatch Tissue Reinforcement | Arthrex, Inc. | 2025-05-29 |
| K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) | ZuriMED Technologies AG | 2024-12-11 |
| K223538 | Integrity Implant | Anika Therapeutics, Inc. | 2023-08-17 |