510(k) K122415 ยท HTY Pin, Fixation, Smooth
X-FIX DYNAMIC EXTERNAL DISTRACTOR
| Applicant | Arex USA, LLC, Edgewater FL, US |
| Decision | Substantially Equivalent, Mar 15, 2013 |
| Received | Aug 8, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122415
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.