510(k) K093629 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM
| Applicant | Biomet Spine, Parsippany NJ, US |
| Decision | Substantially Equivalent, Mar 9, 2010 |
| Received | Nov 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093629
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2013 | Ebi, Llc Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.