K-number	K221787
Device name	Auxein's DHS/DCS Plate System
Applicant	Auxein Medical Private Limited
Product code	KTT
Device class	Class II
Decision date	Nov 30, 2023
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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Auxein's DHS/DCS Plate System

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