K172269

Substantially Equivalent

FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System

Applicant: Globus Medical, Inc.
Product code: PML
Advisory panel: Orthopedic
Date received: 2017-07-28
Decision date: 2018-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PML

product code PML

Death: 8
Total: 8

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.