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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 K250520
Device Name OsteoCentric Navigated Instruments System
Applicant
Osteocentric Technologies, Inc.
75 W. 300 N.
Suite 150
Logan,  UT  84321
Applicant Contact Todd Evans
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/21/2025
Decision Date 10/27/2025
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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