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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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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