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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 K193558
Device Name HEALICOIL Knotless Suture Anchors
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Applicant Contact Camille Black
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Correspondent Contact Camille Black
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received12/23/2019
Decision Date 03/18/2020
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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