K250605
- 510(k) number
- K250605
- Device name
- EVOL® ha Hyper C Cervical Interbody Fusion System
- Applicant
- Cutting Edge Spine, LLC NC · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2025-03-12
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250605.pdf
Official FDA record: K250605
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.