510(k) K083071 ยท KWP Appliance, Fixation, Spinal Interlaminal
VERTEX RECONSTRUCTION SYSTEM
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Nov 14, 2008 |
| Received | Oct 15, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Spinal interlaminal fixation orthosis. Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.