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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 K163428
Device Name HA Minuteman G3-R MIS Fusion Plate
Applicant
Spinal Simplicity
10995 Quivira Rd.
Overland Park,  KS  66210
Applicant Contact Douglas B Snell
Correspondent
Spinal Simplicity
10995 Quivira Rd.
Overland Park,  KS  66210
Correspondent Contact Douglas B Snell
Regulation Number888.3050
Classification Product Code
PEK  
Date Received12/06/2016
Decision Date 02/02/2017
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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