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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
Device Name SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT
Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 beech avenue
unit b6
torrance,  CA  90501
Applicant Contact allyson parks
Correspondent
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 beech avenue
unit b6
torrance,  CA  90501
Correspondent Contact allyson parks
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/28/2012
Decision Date 09/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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