510(k) K965046 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
ISOLA TWISTER CONNECTOR
| Applicant | Acromed Corp., Cleveland OH, US |
| Decision | Substantially Equivalent for Some Indications, Mar 14, 1997 |
| Received | Dec 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965046
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.