510(k) K111166 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
| Applicant | Spineworks, LLC, Round Rock TX, US |
| Decision | Substantially Equivalent, Sep 8, 2011 |
| Received | Apr 26, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111166
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.