510(k) K113048 ยท HRS Plate, Fixation, Bone
MAXLOCK EXTREME SYSTEM
| Applicant | Orthohelix Surgical Designs, Inc., Medina OH, US |
| Decision | Substantially Equivalent, Jan 30, 2012 |
| Received | Oct 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113048
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.