K-number	K212075
Device name	ShurFit Lumbar Interbody System
Applicant	Precision Spine, Inc.
Product code	MAX
Device class	Class II
Decision date	Dec 8, 2021
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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ShurFit Lumbar Interbody System

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