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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K232572
Device Name Kalitec Navigated Instrument System
Applicant
Kalitec Direct, LLC Doing Business AS Kalitec Medical
618 E. S. St., Suite 500
Orlando,  FL  32801
Applicant Contact Winn Scott
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven,  UT  84401
Correspondent Contact J.D. Webb
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
MNI   NKB  
Date Received08/24/2023
Decision Date 12/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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