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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K060290
Device Name SHOULDER FIXATION SYSTEM
Applicant
Hand Innovations, LLC
8905 SW 87th Ave.,
Suite 220
Miami Lakes,  FL  33176
Applicant Contact ERNESTO HERNANDEZ
Correspondent
Hand Innovations, LLC
8905 SW 87th Ave.,
Suite 220
Miami Lakes,  FL  33176
Correspondent Contact ERNESTO HERNANDEZ
Regulation Number888.3030
Classification Product Code
LXT  
Date Received02/06/2006
Decision Date 02/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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