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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 K211602
Device Name Klassic Knee System
Applicant
Total Joint Orthopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Applicant Contact Chris Weaber
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Holly Rhodes
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received05/24/2021
Decision Date 07/23/2021
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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