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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 K170282
Device Name Smith & Nephew VISIONAIRE Adaptive Guides
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 Received01/30/2017
Decision Date 05/22/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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