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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 K103309
Device Name OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
Applicant
Smith & Nephew Endoscopy, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact KATHLEEN SOLOMON
Correspondent
Smith & Nephew Endoscopy, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact KATHLEEN SOLOMON
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
JDR  
Date Received11/10/2010
Decision Date 02/03/2011
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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