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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 K202740
Device Name Klassic Knee System Tibial Inserts, PS-Max
Applicant
Total Joint Orthopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Applicant Contact Chris Weaber
Correspondent
Total Joint Orthopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Correspondent Contact Chris Weaber
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received09/18/2020
Decision Date 10/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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