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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 K151105
Device Name Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture A
Smith & Nephew, Inc.
130 Forbes Boulevard
Mansfield,  MA  02048
Applicant Contact Katherine Marcaccio
Smith & Nephew, Inc.
150 Minuteman Road
Andover,  MA  01810
Correspondent Contact Katherine Marcaccio
Regulation Number888.3030
Classification Product Code
Subsequent Product Codes
Date Received04/24/2015
Decision Date 07/28/2015
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