K-number	K191353
Device name	COMET Lumbar Interbody Fusion Cage
Applicant	Baui Biotech Co., Ltd.
Product code	MAX
Device class	Class II
Decision date	Apr 14, 2020
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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COMET Lumbar Interbody Fusion Cage

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