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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K060736
Device Name SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact DAVID HENSLEY
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact DAVID HENSLEY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/20/2006
Decision Date 04/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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