510(k) K243116 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
FlareHawk Interbody Fusion System
| Applicant | Integrity Implants Inc. Dba Accelus, Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, May 21, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243116
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.