K-number	K103223
Device name	HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS
Applicant	Encore Medical L.P.
Product code	OIY
Device class	Class II
Decision date	Dec 21, 2010
Decision	Substantially Equivalent
Regulation	888.3560

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View the full FDA submission: accessdata.fda.gov

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HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS

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