SABER-XA System— 510(k) K261408

Name: FDA 510(k) clearance K261408
Creator: U.S. Food and Drug Administration
Published: 2026-08-03

Substantially Equivalent

Elevation Spine

FDA 510(k) clearance K261408 for SABER-XA System, Substantially Equivalent on 2026-08-03. Applicant: Elevation Spine. Device class: 2.

Clearance details

Applicant: Elevation Spine
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-04-30
Decision date: 2026-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monteray, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Elevation Spine

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K260660 — SABER-C System2026-04-27
K250540 — SABER-C System2025-08-08
K190885 — Elevation Spine Saber-C System2019-08-07

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.