OPTETRAK LOGIC POROUS FEMORAL COMPONENTS— 510(k) K140302

Name: FDA 510(k) clearance K140302
Creator: U.S. Food and Drug Administration
Published: 2014-07-30

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K140302 for OPTETRAK LOGIC POROUS FEMORAL COMPONENTS, Substantially Equivalent on 2014-07-30. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Product code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2014-02-06
Decision date: 2014-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.