510(k) K042964 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MX MONOAXIAL PEDICLE SCREW
| Applicant | Scient'X, Round Rock TX, US |
| Decision | Substantially Equivalent, Nov 22, 2004 |
| Received | Oct 27, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042964
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.