510(k) K123100 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
INTESS LUMBAR CAGE
| Applicant | Kalitec Direct, LLC, Round Rock TX, US |
| Decision | Substantially Equivalent, Mar 28, 2013 |
| Received | Oct 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123100
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.