510(k) K081097 ยท HTY Pin, Fixation, Smooth
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
| Applicant | Orthopediatrics, LLC, Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 3, 2008 |
| Received | Apr 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081097
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.