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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
Recalls CDRH Recalls
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