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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K210980
Device Name Smith & Nephew Intramedullary Nail Systems
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact Leah Hawkins
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact Michelle Huettner
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
JDS  
Date Received04/01/2021
Decision Date 11/14/2022
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
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