K-number	K193423
Device name	VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
Applicant	Icotec AG
Product code	NKB
Device class	Class II
Decision date	May 22, 2020
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0

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