510(k) K061400 ยท HRS Plate, Fixation, Bone
CALCANEAL TRAUMA SYSTEM
| Applicant | Orthohelix Surgical Designs, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Jun 29, 2006 |
| Received | May 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061400
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.