510(k) K053508 ยท MQP Spinal Vertebral Body Replacement Device
SYNFIX-LR
| Applicant | Synthes Spine Co.Lp, West Chester PA, US |
| Decision | Substantially Equivalent, Feb 13, 2006 |
| Received | Dec 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053508
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2010 | Synthes USA (HQ), Inc. SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure)
The implant holder is used to place the implant into the vertebral disc space. Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.