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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
Recalls CDRH Recalls
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