510(k) K973854 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
ORION ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Sofamor Danek USA,Inc., Memphis TN, US |
| Decision | Substantially Equivalent for Some Indications, Mar 16, 1998 |
| Received | Oct 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973854
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.