510(k) K983353 ยท KWP Appliance, Fixation, Spinal Interlaminal
SCS SPINAL SYSTEM
| Applicant | Orthotec, Inc., Pleasant Hill CA, US |
| Decision | Substantially Equivalent, Dec 18, 1998 |
| Received | Sep 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983353
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.