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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
Recalls CDRH Recalls
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