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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 K083566
Device Name R3 CONSTRAINED LINER, CONSTRAINED LINER
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact JASON SELLS
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact JASON SELLS
Regulation Number888.3310
Classification Product Code
KWZ  
Date Received12/03/2008
Decision Date 03/03/2009
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
Recalls CDRH Recalls
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