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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 K193452
Device Name MotoBAND CP Implant System
Applicant
CrossRoads Extemity Systems, LLC
6055 Primacy Pkwy, Suite 140
Memphis,  TN  38119
Applicant Contact Kim Strohkirch
Correspondent
CrossRoads Extemity Systems, LLC
6055 Primacy Pkwy, Suite 140
Memphis,  TN  38119
Correspondent Contact Kim Strohkirch
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDR  
Date Received12/13/2019
Decision Date 01/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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