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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Augmented Reality
510(k) Number K243623
Device Name SpineAR SNAP (SyncAR Spine)
Applicant
Surgical Theater, Inc.
23645 Mercantile Road
Suite M
Beachwood,  OH  44122
Applicant Contact Kevin Murrock
Correspondent
Surgical Theater, Inc.
23645 Mercantile Road
Suite M
Beachwood,  OH  44122
Correspondent Contact Kevin Murrock
Regulation Number882.4560
Classification Product Code
SBF  
Date Received11/25/2024
Decision Date 12/24/2024
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
Recalls CDRH Recalls
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