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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 Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa
Applicant
Smith & Nephew, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact Katherine Marcaccio
Correspondent
Smith & Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Katherine Marcaccio
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
GAT   HWC   JDR   MBI  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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