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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K223762
Device Name Smith & Nephew ACCORD™ Cable System
Applicant
Smith & Nephew
7135 Goodlett Farns Pkwy.
Cordova,  TN  38016
Applicant Contact Allison Francis
Correspondent
Smith & Nephew
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact Rose Beifuss
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
JDQ  
Date Received12/15/2022
Decision Date 05/30/2023
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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