510(k) K003735 ยท MNI Orthosis, Spinal Pedicle Fixation
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
| Applicant | Blackstone Medical, Inc., Springfield MA, US |
| Decision | Substantially Equivalent, May 8, 2001 |
| Received | Dec 4, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003735
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.