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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nail, fixation, bone
510(k) Number K981529
Device Name TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact JOANN KUHNE
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact JOANN KUHNE
Regulation Number888.3030
Classification Product Code
JDS  
Date Received04/29/1998
Decision Date 07/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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