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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 K111620
Device Name SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS
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  
Subsequent Product Code
HWC  
Date Received06/10/2011
Decision Date 08/23/2011
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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