510(k) K082728 ยท KWP Appliance, Fixation, Spinal Interlaminal
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jan 16, 2009 |
| Received | Sep 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082728
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.