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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 K102982
Device Name ENDOBUTTON DIRECT
Applicant
Smith & Nephew Inc., Endoscopy Division
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact DEANA BOUSHELL
Correspondent
Smith & Nephew Inc., Endoscopy Division
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact DEANA BOUSHELL
Regulation Number888.3030
Classification Product Code
MAI  
Date Received10/07/2010
Decision Date 01/05/2011
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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