510(k) K031511 ยท NQP Posterior Metal/Polymer Spinal System, Fusion
DYNESYS SPINAL SYSTEM
| Applicant | Centerpulse Spine-Tech, Inc., Minneapolis MN, US |
| Decision | Unknown, Mar 5, 2004 |
| Received | May 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031511
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Dynesys Set screw M6 Terminated |
NQP | None listed |
| Nov 6, 2012 | Zimmer, Inc. Dynesys Universal spacer 6-45 Terminated |
NQP | None listed |
| Nov 6, 2012 | Zimmer, Inc. Dynesys L.I.S. Stabilizing cord
Rx, Sterile Terminated |
NPQ | None listed |
| 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.