510(k) K011807 ยท MNI Orthosis, Spinal Pedicle Fixation
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
| Applicant | Ortho Tec, LLC, Chesterland OH, US |
| Decision | Substantially Equivalent, Aug 7, 2001 |
| Received | Jun 11, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011807
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.