510(k) K946348 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)
| Applicant | Sofamor Danek USA,Inc., Memphis TN, US |
| Decision | Substantially Equivalent for Some Indications, Aug 7, 1995 |
| Received | Dec 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946348
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.