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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 K122623
Model 3017-000 (LEFT) AND 3018-000 (RIGHT); 3019-040 (LEFT) AND 3021-040 (RIGHT); 3019-060 (LEFT) AND 3021-060 (RIGHT)
Device Name SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT
Original Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 beech avenue
unit b6
torrance,  CA  90501
Original Contact allyson parks
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/28/2012
Decision Date 09/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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