510(k) K080058 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
TURBO PRIME IBD SYSTEM
| Applicant | Spineselect, LLC, Apple Valley MN, US |
| Decision | Substantially Equivalent, Apr 16, 2008 |
| Received | Jan 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080058
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.