510(k) K093900 ยท HRS Plate, Fixation, Bone
EDGELOCK
| Applicant | Orthohelix Surgical Designs, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Feb 17, 2010 |
| Received | Dec 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093900
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.