K-number	K150619
Device name	CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
Applicant	Orthofix, Inc.
Product code	ODP
Device class	Class II
Decision date	Sep 11, 2015
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System

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