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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 K051310
Device Name PLC SCREW
Applicant
SMITH & NEPHEW, INC.
150 Minuteman Road
Andover,  MA  01810
Applicant Contact BILL MCCALLUM
Correspondent
SMITH & NEPHEW, INC.
150 Minuteman Road
Andover,  MA  01810
Correspondent Contact BILL MCCALLUM
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/19/2005
Decision Date 07/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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