K-number	K153776
Device name	Optetrak One Logic Femoral Components
Applicant	Exactech, Inc.
Product code	MBH
Device class	Class II
Decision date	Mar 10, 2016
Decision	Substantially Equivalent
Regulation	888.3565

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Source

View the full FDA submission: accessdata.fda.gov

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Optetrak One Logic Femoral Components

Everything you need for a 510(k) submission. Nothing you don't.