510(k) K042498 ยท KWP Appliance, Fixation, Spinal Interlaminal
VERTEX RECONSTRUCTION SYSTEM
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Oct 7, 2004 |
| Received | Sep 14, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2011 | Medtronic Sofamor Danek USA Inc VERTEX (R), REF 69004440, cortical screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132
Intended to help provide immobilization and stabilization of spinal segments as Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.