510(k) K964544 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Feb 11, 1997 |
| Received | Nov 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964544
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.