CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments— 510(k) K191835

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K191835 for CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments, Substantially Equivalent on 2019-08-06. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2019-07-09
Decision date: 2019-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Audubon, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.