510(k) K011437 ยท MNI Orthosis, Spinal Pedicle Fixation
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
| Applicant | Interpore Cross Intl., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 6, 2001 |
| Received | May 10, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011437
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.