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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, Nondegradable, Soft Tissue
510(k) Number K093897
Device Name SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIV.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact CHRISTINA FLORES
Correspondent
SMITH & NEPHEW INC., ENDOSCOPY DIV.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact CHRISTINA FLORES
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/18/2009
Decision Date 03/04/2010
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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