510(k) K943819 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
ISOLA ANTERIOR SYSTEM
| Applicant | Acromed Corp., Cleveland OH, US |
| Decision | Substantially Equivalent for Some Indications, Feb 9, 1995 |
| Received | Aug 5, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943819
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.