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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 K170518
Device Name In2Bones Fracture and Correction System
Applicant
In2bones USA, LLC
6060 Poplar Ave.
Suite 380
Memphis,  TN  38119
Applicant Contact Joe Clift
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 Received02/21/2017
Decision Date 07/14/2017
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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