510(k) K112429 ยท MQP Spinal Vertebral Body Replacement Device
GIZA(R) VERTEBRAL BODY REPLACEMENT
| Applicant | Eden Spine, LLC, Apple Valley MN, US |
| Decision | Substantially Equivalent, Jan 26, 2012 |
| Received | Aug 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112429
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2017 | Eden Spine Europe SA GIZA Vertebral Body Replacement Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.