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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 K162035
Device Name GMK Sphere
Applicant
Medacta International SA
Strada Regina
Castel San Pietro,  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Mapi USA, Inc
2343 Alexandria Drive
Suite 100
Lexington,  KY  40504
Correspondent Contact Elizabeth Rose
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/22/2016
Decision Date 03/06/2017
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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