K031508

Substantially Equivalent

SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM

Applicant: Synthes (Usa)
Product code: JDQ
Advisory panel: Orthopedic
Date received: 2003-05-14
Decision date: 2003-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, 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.