510(k) K012175 ยท MNI Orthosis, Spinal Pedicle Fixation
PASS SPINAL SYSTEM
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jul 31, 2001 |
| Received | Jul 12, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012175
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.