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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 K234051
Device Name Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3
Applicant
Spinal Simplicity, LLC
6363 College Blvd.
Suite 320
Overland Park,  KS  66211
Applicant Contact Adam Rogers
Correspondent
Spinal Simplicity, LLC
6363 College Blvd.
Suite 320
Overland Park,  KS  66211
Correspondent Contact Adam Rogers
Regulation Number888.3050
Classification Product Code
PEK  
Date Received12/21/2023
Decision Date 01/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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