K-number	K180458
Device name	FOCUS Pedicle Screw System
Applicant	Nvision Biomedical Technologies, LLC
Product code	NKB
Device class	Class II
Decision date	Apr 17, 2018
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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FOCUS Pedicle Screw System

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