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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 K252087
Device Name Navigation Module of the Cortium® System
Applicant
Ulrich Medical USA, Inc.
3700 E Plano Pkwy.
Suite 200
Plano,  TX  75074
Applicant Contact Eric Lucas
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/02/2025
Decision Date 02/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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