DeviceClearance

K912370

Substantially Equivalent

HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)

Applicant
Biomet, Inc.
Product code
MEH
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 MEH

product code MEH
Injury
2,021
Total
2,021

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.