K-number	K143388
Device name	Affix IIS Spinous Process Plate System
Applicant	Nu Vasive, Incorporated
Product code	PEK
Device class	Class II
Decision date	Mar 5, 2015
Decision	Substantially Equivalent
Regulation	888.3050

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Source

View the full FDA submission: accessdata.fda.gov

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Affix IIS Spinous Process Plate System

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