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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K093844
Device Name SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
Applicant
SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact CHRISTINA FLORES
Correspondent
SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact CHRISTINA FLORES
Regulation Number888.3030
Classification Product Code
MAI  
Date Received12/15/2009
Decision Date 04/01/2010
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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