510(k) K132733 ยท HTN Washer, Bolt Nut
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
| Applicant | Orthohelix Surgical Designs, Inc., Medina OH, US |
| Decision | Substantially Equivalent, Jan 3, 2014 |
| Received | Sep 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132733
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.