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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 K122737
Model NARROW 3 HOLE, RIGHT AND LEFT, NARROW 4 HOLE, RIGHT AND LIGHT, STANDARD 3 HOLE, RIGHT AND LEFT, STANDARD 4 HOLE, RIGHT
Device Name GEMINUS FOSSA SPECIFIC PLATE SYSTEM
Original Applicant
SKELETAL DYNAMICS, LLC
8905 sw 87 avenue, suite 201
miami,  FL  33176
Original Contact ana m escagedo
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/06/2012
Decision Date 10/03/2012
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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