510(k) K251690 · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Arthrex SpeedFLEX Implant
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Sep 30, 2025 |
| Received | Jun 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251690
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.