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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 K023921
Device Name JET-X HA COATED HALF PINS
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact DAVID HENLEY
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact DAVID HENLEY
Regulation Number888.3040
Classification Product Code
JDW  
Date Received11/25/2002
Decision Date 02/05/2003
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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