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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 K111635
Device Name SMITH & NEPHEW RJ CONSTRAINED LINERS
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact MEGAN BEVILL
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact MEGAN BEVILL
Regulation Number888.3310
Classification Product Code
KWZ  
Date Received06/13/2011
Decision Date 09/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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