510(k) K953635 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
TITANIUM DYNA-LOK SPINAL SYSTEM
| Applicant | Sofamor Danek USA,Inc., Winona Lake IN, US |
| Decision | Substantially Equivalent for Some Indications, Oct 30, 1995 |
| Received | Aug 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953635
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.