510(k) K181337 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Sypher Spacer System
| Applicant | Biogennix, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 18, 2018 |
| Received | May 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181337
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.