510(k) K251382 ยท HWC Screw, Fixation, Bone
Phoenix Sinus Tarsi Stent System
| Applicant | Astra Orthomed, Inc., Brentwood TN, US |
| Decision | Substantially Equivalent, Aug 27, 2025 |
| Received | May 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251382
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.