510(k) K241219 ยท OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
| Applicant | ZuriMED Technologies AG, Zurich, CH |
| Decision | Substantially Equivalent, Dec 11, 2024 |
| Received | May 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241219
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.