510(k) K112068 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
SYNTHES ZERO-P VARIABLE ANGLE (VA)
| Applicant | Synthes Spine Co.Lp, West Chester PA, US |
| Decision | Substantially Equivalent, Nov 7, 2011 |
| Received | Jul 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2013 | Synthes USA HQ, Inc. Synthes Zero-P VA Implant 7 MM Height Parallel Sterile
The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skele Terminated |
OVE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.