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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 K162829
Device Name Medline UNITE® Ankle Fracture Plating System
Applicant
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Applicant Contact Jennifer Mason
Correspondent
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Correspondent Contact Jennifer Mason
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received10/07/2016
Decision Date 12/09/2016
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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