510(k) K100138 ยท MNI Orthosis, Spinal Pedicle Fixation
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
| Applicant | Alphatec Spine, Inc., Carlsnad CA, US |
| Decision | Substantially Equivalent, Feb 17, 2010 |
| Received | Jan 19, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100138
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.