510(k) K081044— REJUVENATE MODULAR HIP SYSTEM
Substantially EquivalentHowmedica Osteonics Corp.
Clearance details
- Applicant
- Howmedica Osteonics Corp.
- Product code
- Code MEH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mahwah, NJ, US
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.