510(k) K024096 ยท MNI Orthosis, Spinal Pedicle Fixation
OPTIMA, SPINAL SYSTEM
| Applicant | U&I Corp., America, Murray UT, US |
| Decision | Substantially Equivalent, Mar 12, 2003 |
| Received | Dec 12, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024096
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2004 | U&I America Optima Spinal System and Spinal Hook System, set screw component. Terminated |
MNI | None listed |
| Feb 27, 2004 | U&I America 2.5mm Hex Driver Terminated |
MNI | None listed |
| Feb 27, 2004 | U&I America 4mm Hex Driver Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.