SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments— 510(k) K260571

Substantially Equivalent

Life Spine, Inc.

FDA 510(k) clearance K260571 for SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments, Substantially Equivalent on 2026-06-02. Applicant: Life Spine, Inc..

Clearance details

Applicant: Life Spine, Inc.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2026-02-19
Decision date: 2026-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntley, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.