510(k) K081297 ยท KWP Appliance, Fixation, Spinal Interlaminal
VERTEX RECONSTRUCTION SYSTEM
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Jun 11, 2008 |
| Received | May 7, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2020 | Medtronic Sofamor Danek USA Inc VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.