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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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K211512
Device Name VISIONAIRE UK Patient Matched Cutting Guides
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Applicant Contact Leah Hawkins
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Correspondent Contact Leah Andre
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Codes
JWH   MBH   OOG  
Date Received05/14/2021
Decision Date 09/16/2021
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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