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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 K213491
Device Name Universal Pilot Guidance Instrument System
Applicant
Ctl Medical Corporation
4550 Excel Pkwy.
Suite 300
Addison,  TX  75001
Applicant Contact Sean Suh
Correspondent
Omni Strategic Solutions, LLC
700 Pennsylvania Ave. SE
2nd Floor
Washington,  DC  20003
Correspondent Contact Dhaval Saraiya
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/01/2021
Decision Date 05/12/2022
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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