K-number	K181978
Device name	Zenius, Iliad and Kora Spinal Fixation Systems
Applicant	Medyssey USA, Inc.
Product code	NKB
Device class	Class II
Decision date	Aug 13, 2018
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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Zenius, Iliad and Kora Spinal Fixation Systems

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Zenius, Iliad and Kora Spinal Fixation Systems