SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments— 510(k) K183119

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K183119 for SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments, Substantially Equivalent on 2019-02-06. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2018-11-09
Decision date: 2019-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.