510(k) K113796 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
SOLITAIRE-C CERVICAL SPACER SYSTEM
| Applicant | Ebi, LLC, Parsippany NJ, US |
| Decision | Substantially Equivalent, Apr 26, 2012 |
| Received | Dec 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2014 | Ebi, Llc Solitaire-C Cervical Spacer System
a) 14-531593 Drill/Awl Sleeve
b) 14-531594 Spring-Loaded Drill/Awl Sleeve
Intended to stabilize cervical spinal segment to promote fusion in order to restrict moti Terminated |
OVE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.