K-number	K190418
Device name	NuVasive® VersaTie® System
Applicant	Nu Vasive, Incorporated
Product code	OWI
Device class	Class II
Decision date	Mar 21, 2019
Decision	Substantially Equivalent
Regulation	888.3010

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Source

View the full FDA submission: accessdata.fda.gov

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NuVasive® VersaTie® System

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