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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, constrained, cemented or uncemented, metal/polymer
510(k) Number K122139
Device Name SMITH & NEPHEW R3 CONSTRAINED LINERS
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis,  TN  38116
Original Contact martin ostmann
Regulation Number888.3310
Classification Product Code
KWZ  
Date Received07/19/2012
Decision Date 10/16/2012
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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