510(k) K980485 ยท MNI Orthosis, Spinal Pedicle Fixation
ISOLA SPINAL SYSTEM
| Applicant | Acromed Corp., Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 21, 1998 |
| Received | Feb 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980485
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.