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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 K031685
Device Name TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
Applicant
Smith & Nephew, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact JASON BILOBRAM
Correspondent
Smith & Nephew, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact JASON BILOBRAM
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/02/2003
Decision Date 07/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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