510(k) K253867 ยท OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
| Applicant | ZuriMED Technologies AG, Zurich, CH |
| Decision | Substantially Equivalent, Jan 2, 2026 |
| Received | Dec 3, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253867
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.