510(k) K010576 ยท MNI Orthosis, Spinal Pedicle Fixation
MONARCH SPINE SYSTEM
| Applicant | Depuyacromed, Raynham MA, US |
| Decision | Substantially Equivalent, May 23, 2001 |
| Received | Feb 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010576
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.