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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 K230880
Device Name CoreLink Navigation Instruments
Applicant
Corelink, LLC
2072 Fenton Logistics Park
St. Louis,  MO  63026
Applicant Contact Steven Mounts
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
NKB  
Date Received03/30/2023
Decision Date 05/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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