510(k) K250605 · ODP Intervertebral Fusion Device With Bone Graft, Cervical
EVOL® ha Hyper C Cervical Interbody Fusion System
| Applicant | Cutting Edge Spine, LLC, Mineral Springs NC, US |
| Decision | Substantially Equivalent, Mar 12, 2025 |
| Received | Feb 28, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250605
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.