510(k) K080075 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
| Applicant | Elite Surgical Supplies (Pty), Ltd., Marietta GA, US |
| Decision | Substantially Equivalent, Jan 28, 2008 |
| Received | Jan 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080075
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.