DeviceClearance

K213563

Substantially Equivalent

DePuy Synthes Radial Head Replacement System

Applicant
DePuy Synthes
Product code
KWI
Advisory panel
Orthopedic
Date received
Decision date
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, through . 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.