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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 K111711
Device Name JOURNEY II BCS KNEE SYSTEM
Applicant
SMITH & NEPHEW, INC.
7135 GOODLET FARMS PARKWAY
MEMPHIS,  TN  38116
Applicant Contact SHEREEN MYERS
Correspondent
SMITH & NEPHEW, INC.
7135 GOODLET FARMS PARKWAY
MEMPHIS,  TN  38116
Correspondent Contact SHEREEN MYERS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/20/2011
Decision Date 09/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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