510(k) K081395 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
| Applicant | Biomet Spine, Parsippany NJ, US |
| Decision | Substantially Equivalent, Jun 25, 2008 |
| Received | May 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081395
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.