K-number	K162849
Device name	Huvex Interspinous Fixation System
Applicant	Dio Medical Co., Ltd.
Product code	PEK
Device class	Class II
Decision date	Feb 16, 2017
Decision	Substantially Equivalent
Regulation	888.3050

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Source

View the full FDA submission: accessdata.fda.gov

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Huvex Interspinous Fixation System

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