510(k) K895607— POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
Substantially Equivalent for Some IndicationsExactech, Inc.
Clearance details
- Applicant
- Exactech, Inc.
- Product code
- Code JDL
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Gainesville, FL, US
Adverse events under product code JDL
product code JDL- Injury
- 285
- Total
- 285
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.