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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, ankle, semi-constrained, cemented, metal/polymer
510(k) Number K122395
Device Name DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw,  IN  46581 0988
Original Contact megan burns
Regulation Number888.3110
Classification Product Code
HSN  
Date Received08/07/2012
Decision Date 10/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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