510(k) K072981 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
SYNTHES ZERO-P
| Applicant | Synthes Spine Co.Lp, West Chester PA, US |
| Decision | Substantially Equivalent, Feb 11, 2008 |
| Received | Oct 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072981
| 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 |
| Jun 10, 2009 | Synthes Spine Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide. Terminated |
ODP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.