510(k) K031585 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
U&I, OPTIMA, SPINAL SYSTEM
| Applicant | U&I Corp., America, Murray UT, US |
| Decision | Substantially Equivalent, Jun 27, 2003 |
| Received | May 21, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031585
| 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 |
| Aug 27, 2003 | U&I America Optima Poly Screw Driver. Terminated |
MNI | None listed |
| Aug 27, 2003 | U&I America Optima Large Poly Screw Driver Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.