510(k) K093762 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
SYNTHES ZERO-P
| Applicant | Synthes Spine, West Chester PA, US |
| Decision | Substantially Equivalent, Dec 20, 2010 |
| Received | Dec 7, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093762
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2011 | Synthes USA (HQ), Inc. Synthes Spine Zero-P Instruments and Implants.
Zero-profile anterior cervical interbody fusion (ACIF) device. Terminated |
ODP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.