510(k) K024313 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
| Applicant | Pisharodi Surgicals, Inc., Round Rock TX, US |
| Decision | Substantially Equivalent, Aug 29, 2003 |
| Received | Dec 24, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K024313
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.