K-number	K241019
Device name	aprevo® TLIF-C Articulating System
Applicant	Carlsmed
Product code	MAX
Device class	Class II
Decision date	Jul 9, 2024
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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aprevo® TLIF-C Articulating System

Everything you need for a 510(k) submission. Nothing you don't.