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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 Parkway
Cordova,  TN  38016
Applicant Contact Brad Sheals
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
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
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