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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 K140372
Device Name FRAGMENT PLATE SYSTEM
Applicant
Skeletal Dynamics, LLC
8905 SW 87 Ave., Suite 201
Miami,  FL  33176
Applicant Contact ANA M ESCAGEDO
Correspondent
Skeletal Dynamics, LLC
8905 SW 87 Ave., Suite 201
Miami,  FL  33176
Correspondent Contact ANA M ESCAGEDO
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/14/2014
Decision Date 04/07/2014
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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