DeviceClearance

K091161

Substantially Equivalent

REJUVENATE MONOLITHIC SIZE 4 HIP STEM

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