SABER-XA System— 510(k) K261408
Substantially EquivalentElevation Spine
FDA 510(k) clearance K261408 for SABER-XA System, Substantially Equivalent on 2026-08-03. Applicant: Elevation Spine. Device class: 2.
Summary
Elevation Spine's SABER-XA System is filed under product code OVD, lumbar intervertebral fusion devices with integrated fixation. The record gives no model numbers.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).
The record lists the applicant location as Monteray, California. The decision came 95 calendar days after receipt (April 30 to August 3, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Elevation Spine
- Product code
- Product code OVD
- 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 OVD
view allMore clearances from Elevation Spine
view allAdverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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.