510(k) K260995 · HWC Screw, Fixation, Bone
DynaNail Helix® Fixation System
| Applicant | MedShape, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, Sep 23, 2026 |
| Received | Mar 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260995
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.