510(k) K911528 ยท KWP Appliance, Fixation, Spinal Interlaminal
ISOLA(TM) SPINE SYSTEM - ILIAC SCREW
| Applicant | Acromed Corp., Cleveland OH, US |
| Decision | Substantially Equivalent for Some Indications, Jun 28, 1991 |
| Received | Apr 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911528
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.