K-number	K232572
Device name	Kalitec Navigated Instrument System
Applicant	Kalitec Direct, LLC Doing Business AS Kalitec Medical
Product code	OLO
Device class	Class II
Decision date	Dec 13, 2023
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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Kalitec Navigated Instrument System

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