DePuy Synthes Radial Head Replacement System— 510(k) K213563

Substantially Equivalent

DePuy Synthes

FDA 510(k) clearance K213563 for DePuy Synthes Radial Head Replacement System, Substantially Equivalent on 2022-03-18. Applicant: DePuy Synthes.

Clearance details

Applicant: DePuy Synthes
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 2021-11-09
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.