510(k) K103320 ยท MQP Spinal Vertebral Body Replacement Device
SYNTHES XRL
| Applicant | Synthes Spine Co.Lp, West Chester PA, US |
| Decision | Substantially Equivalent, Oct 20, 2011 |
| Received | Nov 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103320
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2014 | Synthes, Inc. Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.