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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 Parkway
Cordova,  TN  38016
Applicant Contact DAVID HENLEY
Correspondent
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  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
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