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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 K183010
Device Name Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Applicant Contact Brad Sheals
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Correspondent Contact Brad Sheals
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OOG  
Date Received10/31/2018
Decision Date 11/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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