SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS— 510(k) K081205

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K081205 for SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS, Substantially Equivalent on 2008-07-01. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2008-04-29
Decision date: 2008-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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.