510(k) K010922 ยท MNI Orthosis, Spinal Pedicle Fixation
TRI-FIX SPINAL FIXATION SYSTEM
| Applicant | Endius, Inc., Plainville MA, US |
| Decision | Substantially Equivalent, Jun 6, 2001 |
| Received | Mar 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010922
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.