510(k) K110177 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
HELENA SYSTEM
| Applicant | Royal Oak Medical Devices, Bloomfield Hills MI, US |
| Decision | Substantially Equivalent, Apr 21, 2011 |
| Received | Jan 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110177
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.