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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 K093978
Device Name EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville,  FL  32653
Original Contact shing jen tai
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/24/2009
Decision Date 05/11/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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