510(k) K033826 ยท MNI Orthosis, Spinal Pedicle Fixation
ORTHOPEDIC ALLIANCE SPINE SYSTEM
| Applicant | Orthopedic Alliance, LLC, Murrieta CA, US |
| Decision | Substantially Equivalent, Jul 1, 2004 |
| Received | Dec 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033826
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2013 | Orthopedic Alliance LLC Orthopedic Alliance Spine System (alias "Blue & Gold")
Part Numbers:
BGC3010 Screw Cap
BGR0040 Straight Rod 5.5 x 40mm
BGR0050 Straight Rod 5.5 x 50mm
BGR0060 Straight Rod 5.5 x 60mm
BGR0070 Straigh Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.