510(k) K160545 ยท HSB Rod, Fixation, Intramedullary And Accessories
GAP ENDO-EXO MEDULLARY SYSTEM
| Applicant | Pega Medical, Inc., Laval, CA |
| Decision | Substantially Equivalent, Nov 23, 2016 |
| Received | Feb 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160545
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.