510(k) K911394 ยท KWP Appliance, Fixation, Spinal Interlaminal
ISOLA(TM) SPINE SYSTEM--EYE ROD
| Applicant | Acromed Corp., Cleveland OH, US |
| Decision | Substantially Equivalent, Jun 21, 1991 |
| Received | Mar 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911394
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.