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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 K211254
Device Name ARAI Surgical Navigation System
Applicant
Surgalign Spine Technologies
520 Lake Cook Road, Suite 315
Deerfield,  IL  60015
Applicant Contact Cristian Luciano
Correspondent
Surgalign Spine Technologies
520 Lake Cook Road, Suite 315
Deerfield,  IL  60015
Correspondent Contact Jeremy Markovich
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received04/26/2021
Decision Date 01/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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