K-number	K231140
Device name	aprevo® transforaminal lumbar interbody fusion device
Applicant	Carlsmed, Inc.
Product code	MAX
Device class	Class II
Decision date	May 19, 2023
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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aprevo® transforaminal lumbar interbody fusion device

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