SABER-C System— 510(k) K260660
Substantially EquivalentElevation Spine
FDA 510(k) clearance K260660 for SABER-C System, Substantially Equivalent on 2026-04-27. Applicant: Elevation Spine. Device class: 2.
Summary
Elevation Spine's SABER-C System is filed under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3080. It came in as a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
Elevation Spine filed from Monteray, California. Review took 56 calendar days (March 2 to April 27, 2026).
Clearance details
- Applicant
- Elevation Spine
- Product code
- Product code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monteray, CA, US
Recent devices under product code OVE
view allMore clearances from Elevation Spine
view allAdverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.