Optetrak One Logic Femoral Components— 510(k) K153776
Substantially EquivalentExactech, Inc.
FDA 510(k) clearance K153776 for Optetrak One Logic Femoral Components, Substantially Equivalent on 2016-03-10. Applicant: Exactech, Inc.. Device class: 2.
Clearance details
- Applicant
- Exactech, Inc.
- Product code
- Code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gainesville, FL, US
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More clearances from Exactech, Inc.
view allAdverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
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.