DeviceClearance

K133940

Substantially Equivalent

OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)

Applicant
Biomet UK, Ltd.
Product code
HRY
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY
Injury
1,551
Malfunction
2,753
Total
4,304

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.