K153242

Substantially Equivalent

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System

Applicant: Frontier Medical Devices, Inc.
Product code: JDQ
Advisory panel: Orthopedic
Date received: 2015-11-09
Decision date: 2016-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwinn, MI, US

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.