510(k) K030958 ยท MNI Orthosis, Spinal Pedicle Fixation
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
| Applicant | Ortho Tec, LLC, California CA, US |
| Decision | Substantially Equivalent, Nov 20, 2003 |
| Received | Mar 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030958
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.