510(k) K063453 ยท MNI Orthosis, Spinal Pedicle Fixation
VERTEFIX PEDICLE SCREW SPINAL SYSTEM
| Applicant | Elite Surgical Supplies (Pty), Ltd., Marietta GA, US |
| Decision | Substantially Equivalent, Aug 30, 2007 |
| Received | Nov 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063453
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.