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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K230555
Device Name Cemented Tibia Baseplate no Taper with JRNY Lock
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact Madison Padgett
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact Madison Padgett
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/28/2023
Decision Date 03/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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