K-number	K191494
Device name	Facilis Spinal System
Applicant	Baui Biotech Co., Ltd.
Product code	NKB
Device class	Class II
Decision date	Aug 12, 2019
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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Facilis Spinal System

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Facilis Spinal System