QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments— 510(k) K161591

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K161591 for QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments, Substantially Equivalent on 2016-09-21. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2016-06-09
Decision date: 2016-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

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Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.