510(k) K060638 ยท NQP Posterior Metal/Polymer Spinal System, Fusion
DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS
| Applicant | Zimmer Spine, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 6, 2006 |
| Received | Mar 10, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060638
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Dynesys HA Pedicle + set screw Terminated |
NQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.