510(k) K261647 ยท HRS Plate, Fixation, Bone
Tempo Plating System; Ultra Compression Screw System
| Applicant | Pace Surgical, Malvern PA, US |
| Decision | Substantially Equivalent, Sep 3, 2026 |
| Received | May 19, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261647
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.