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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 K211880
Device Name Minuteman G5 MIS Fusion Plate
Applicant
Spinal Simplicity LLC
6600 College Blvd, Ste 220
Overland Park,  KS  66211
Applicant Contact Adam Rogers
Correspondent
Spinal Simplicity LLC
6600 College Blvd, Ste 220
Overland Park,  KS  66211
Correspondent Contact Adam Rogers
Regulation Number888.3050
Classification Product Code
PEK  
Date Received06/21/2021
Decision Date 03/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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