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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K082215
Device Name OSTEORAPTOR SUTURE ANCHOR
Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact JULIE ACKER
Correspondent
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact JULIE ACKER
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Codes
HWC   MAI  
Date Received08/06/2008
Decision Date 11/03/2008
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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