510(k) K093207 ยท MQP Spinal Vertebral Body Replacement Device
ENDURAMESH, MODEL 762.XXX
| Applicant | Lucero Medical, LLC, Richfield OH, US |
| Decision | Substantially Equivalent, Apr 26, 2010 |
| Received | Oct 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093207
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2012 | Lucero Medical LLC Enduramesh Corpectomy Spacer System
Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or u Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.