Klassic Knee System Tibial Inserts, PS-Max

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Total Joint Orthopedics, Inc.

The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Knee System Tibial Inserts, Ps-max.

Pre-market Notification Details

Device IDK202740
510k NumberK202740
Device Name:Klassic Knee System Tibial Inserts, PS-Max
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City,  UT  84106
ContactChris Weaber
CorrespondentChris Weaber
Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City,  UT  84106
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-18
Decision Date2020-10-09

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