DeviceClearance

K911728

Substantially Equivalent

OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C

Applicant
Osteonics Corp.
Product code
MEH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Allendale, NJ, 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.