510(k) K905184 ยท KWP Appliance, Fixation, Spinal Interlaminal
ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK
| Applicant | Acromed Corp., Cleveland OH, US |
| Decision | Substantially Equivalent for Some Indications, Feb 15, 1991 |
| Received | Nov 19, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905184
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.