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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 K160300
Device Name MotoBand(TM) CP Implant System
Applicant
CrossRoads Extremity Systems, LLC
6055 Primacy Pkwy Suite 140
Memphis,  TN  38119
Applicant Contact Vernon Hartdegen
Correspondent
CrossRoads Extremity Systems, LLC
6055 Primacy Pkwy Suite 140
Memphis,  TN  38119
Correspondent Contact Vernon Hartdegen
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/04/2016
Decision Date 04/22/2016
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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