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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 K211004
Device Name GMK Spherika Femurs and Fixed Tibial Trays Plus
Applicant
Medacta International SA
Strada Regina
Castel San Pietro,  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp Street
Memphis,  TN  83118
Correspondent Contact Chris Lussier
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/02/2021
Decision Date 05/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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