510(k) K931381 ยท KWP Appliance, Fixation, Spinal Interlaminal
AME UNIVERSAL FIXATION SYSTEM
| Applicant | American Medical Electronics, Inc., Richardson TX, US |
| Decision | Substantially Equivalent for Some Indications, Feb 1, 1995 |
| Received | Mar 18, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931381
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.