510(k) K043565 ยท NQP Posterior Metal/Polymer Spinal System, Fusion
MODIFICATION TO DYNESYS SPINAL SYSTEM
| Applicant | Zimmer Spine, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 11, 2005 |
| Received | Dec 27, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043565
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Dynesys Revision + 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.