DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long— 510(k) K163046

Substantially Equivalent

DePuy Synthes

FDA 510(k) clearance K163046 for DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long, Substantially Equivalent on 2017-02-09. Applicant: DePuy Synthes.

Clearance details

Applicant: DePuy Synthes
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2016-11-01
Decision date: 2017-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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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.