K-number	K100197
Device name	GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
Applicant	Smith & Nephew, Inc.
Product code	HSX
Device class	Class II
Decision date	Feb 19, 2010
Decision	Substantially Equivalent
Regulation	888.3520

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View the full FDA submission: accessdata.fda.gov

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GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS

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