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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K200066
Device Name Posterior Fusion Plate, HA Posterior Fusion Plate
Applicant
Spinal Simplicity, LLC
6600 College Blvd., Suite 220
Overland Park,  KS  66211
Applicant Contact Adam Rogers
Correspondent
Spinal Simplicity, LLC
6600 College Blvd., Suite 220
Overland Park,  KS  66211
Correspondent Contact Adam Rogers
Regulation Number888.3050
Classification Product Code
PEK  
Date Received01/13/2020
Decision Date 12/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT01455805
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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