K-number	K191791
Device name	TranS1 Interbody Fusion System
Applicant	Trans1
Product code	MAX
Device class	Class II
Decision date	Sep 25, 2019
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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TranS1 Interbody Fusion System

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