K-number	K171749
Device name	Velofix(tm) Interbody Fusion System
Applicant	U&I Corporation
Product code	ODP
Device class	Class II
Decision date	Jul 13, 2017
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Velofix(tm) Interbody Fusion System

Everything you need for a 510(k) submission. Nothing you don't.