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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(K) Number K121443
Device Name JOURNEY II CR KNEE SYSTEM
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis,  TN  38116
Contact shereen myers
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/15/2012
Decision Date 08/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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