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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 K231611
Device Name HOLO Portal™ Surgical Guidance System
Applicant
Surgalign Spine Technologies
520 Lake Cook Road Suite 315
Deerfield,  IL  60015
Applicant Contact Jeremy Markovich
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 Received06/02/2023
Decision Date 08/31/2023
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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