510(k) K183184 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
FlareHawk Interbody Fusion System
| Applicant | Integrity Implants, Inc., Jupiter FL, US |
| Decision | Substantially Equivalent, Apr 3, 2019 |
| Received | Nov 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183184
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.