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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 K213034
Device Name SpineAR SNAP
Applicant
Surgical Theater, Inc.
30559 Pinetree Road, Suite 206
Pepper Pike,  OH  44124
Applicant Contact Kevin Murrock
Correspondent
Surgical Theater, Inc.
30559 Pinetree Road, Suite 206
Pepper Pike,  OH  44124
Correspondent Contact Kevin Murrock
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received09/21/2021
Decision Date 09/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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