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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 K093428
Device Name SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
Applicant
Smith & Nephew Endoscopy, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact KATHY REDDIG
Correspondent
Smith & Nephew Endoscopy, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact KATHY REDDIG
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/03/2009
Decision Date 12/17/2009
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
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