510(k) K072253 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SYNFIX-LR SPACER
| Applicant | Synthes Spine Co.Lp, West Chester PA, US |
| Decision | Substantially Equivalent, Oct 12, 2007 |
| Received | Aug 14, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072253
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2009 | Synthes Spine Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231.
The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contig Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.