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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 K151741
Device Name HA Minuteman G3 MIS Fusion Plate
Applicant
Spinal Simplicity, LLC
10995 Quivira Rd.
Overland Park,  KS  66210
Applicant Contact JULIE MCKEE
Correspondent
Hogans Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact JANICE M. HOGAN
Regulation Number888.3050
Classification Product Code
PEK  
Date Received06/26/2015
Decision Date 08/20/2015
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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