K-number	K173201
Device name	UNITY Sacroiliac Joint Fixation System
Applicant	Huvexel Co. , Ltd.
Product code	OUR
Device class	Class II
Decision date	Apr 26, 2018
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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UNITY Sacroiliac Joint Fixation System

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