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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K033289
Device Name MODIFICATION TO JET-X HA COATED HALF PINS
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Applicant Contact DAVID HENLEY
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Correspondent Contact DAVID HENLEY
Regulation Number888.3040
Classification Product Code
JDW  
Date Received10/14/2003
Decision Date 01/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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