K-number	K202666
Device name	CONSTRUX Mini PTC Spacer System
Applicant	Orthofix, Inc.
Product code	ODP
Device class	Class II
Decision date	Oct 14, 2020
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 PTC Spacer System

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