510(k) K121693 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)
| Applicant | Sapphire Medical Group, Inc., Vero Beach FL, US |
| Decision | Substantially Equivalent, Dec 27, 2012 |
| Received | Jun 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121693
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.