K-number	K162237
Device name	XO1 Knee Balancing System
Applicant	Xpandortho, Inc.
Product code	ONN
Device class	Class II
Decision date	Apr 25, 2017
Decision	Substantially Equivalent
Regulation	882.4560

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View the full FDA submission: accessdata.fda.gov

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XO1 Knee Balancing System

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