510(k) K994288 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
5.0MM SPINAL SCREWS
| Applicant | Ortho Tec, LLC, Pleasant Hill CA, US |
| Decision | Substantially Equivalent, Apr 10, 2000 |
| Received | Dec 20, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K994288
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.