K-number	K162795
Device name	PROPHECY INVISION Preoperative Navigation Alignment System
Applicant	Wrightmedicaltechnologyinc
Product code	HSN
Device class	Class II
Decision date	Feb 22, 2017
Decision	Substantially Equivalent
Regulation	888.3110

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Source

View the full FDA submission: accessdata.fda.gov

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PROPHECY INVISION Preoperative Navigation Alignment System

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