510(k) K161778 · HWC Screw, Fixation, Bone
ToeTac 10° Hammertoe Fixation System
| Applicant | Restore Surgical, LLC Dba Instratek, Houston TX, US |
| Decision | Substantially Equivalent, Nov 22, 2016 |
| Received | Jun 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161778
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.