DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System— 510(k) K233665

Substantially Equivalent

DePuy Synthes

FDA 510(k) clearance K233665 for DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System, Substantially Equivalent on 2024-03-21. Applicant: DePuy Synthes.

Clearance details

Applicant: DePuy Synthes
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2023-11-15
Decision date: 2024-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.