510(k) K100089 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
SYNTHES T-PAL SPACER
| Applicant | Synthes Spine, West Chester PA, US |
| Decision | Substantially Equivalent, May 13, 2010 |
| Received | Jan 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100089
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2011 | Synthes USA (HQ), Inc. Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system.
Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in pa Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.