510(k) clearance
SABER-C System
- 510(k) number
- K263049
- Applicant
- Elevation Spine
- Decision date
- Sep 23, 2026
- Date received
- Aug 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- OVE
- Device type
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device class
- Class II
- Regulation
- 21 CFR 888.3080
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Monteray, CA, US