510(k) K120557 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35
| Applicant | Biomet Spine & Bone Healing Technologies, Parsippany NJ, US |
| Decision | Substantially Equivalent, Mar 19, 2012 |
| Received | Feb 24, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120557
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.