FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM— 510(k) K141106

Substantially Equivalent

Folsom Metal Products, Inc. Dba Frontier Devices

FDA 510(k) clearance K141106 for FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM, Substantially Equivalent on 2014-10-10. Applicant: Folsom Metal Products, Inc. Dba Frontier Devices.

Clearance details

Applicant: Folsom Metal Products, Inc. Dba Frontier Devices
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2014-04-29
Decision date: 2014-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pelham, AL, 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.