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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 K190280
Device Name Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly
Applicant
Total Joint Orthopedics, Inc.
1567 East Stratford Avenue
Salt Lake City,  UT  84106
Applicant Contact Chris Weaber
Correspondent
Total Joint Orthopedics, Inc.
1567 East Stratford Avenue
Salt Lake City,  UT  84106
Correspondent Contact Chris Weaber
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY  
Date Received02/08/2019
Decision Date 03/15/2019
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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