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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K171293
Device Name G3™ Active Plate® Miniature System
Applicant
Genesis Fracture Care, Inc.
13568 SE 97th Ave., Suite 202
Clackamas,  OR  97015
Applicant Contact Michael Bottlang
Correspondent
Mrc-X, LLC
6075 Poplar Ave., Suite 500
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/02/2017
Decision Date 10/23/2017
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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