510(k) K043001 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MX POLYAXIAL PEDICLE SCREW
| Applicant | Scient'X, Round Rock TX, US |
| Decision | Substantially Equivalent, Dec 1, 2004 |
| Received | Nov 1, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043001
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.