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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 K163293
Device Name Colink™ Plating System
Applicant
IN2BONESUSA, LLC
6060 POPLAR AVE
SUITE 380
MEMPHIS,  TN  38119
Applicant Contact JOE CLIFT
Correspondent
ENMED INTERNATIONAL, INC
PO BOX 249
DEL MAR,  CA  92014
Correspondent Contact LOUISE FOCHT
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/22/2016
Decision Date 05/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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