510(k) K001535 ยท KWP Appliance, Fixation, Spinal Interlaminal
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
| Applicant | Ortho Tec, LLC, Pleasant Hill CA, US |
| Decision | Substantially Equivalent, Mar 20, 2001 |
| Received | May 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001535
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.