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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 K071071
Device Name CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
Applicant
SMITH & NEPHEW, INC.
1450 E BROOKS ROAD
MEMPHIS,  TN  38116
Applicant Contact RISHI SINHA
Correspondent
SMITH & NEPHEW, INC.
1450 E BROOKS ROAD
MEMPHIS,  TN  38116
Correspondent Contact RISHI SINHA
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received04/16/2007
Decision Date 09/19/2007
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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