Klassic Knee System

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.

Pre-market Notification Details

Device IDK153310
510k NumberK153310
Device Name:Klassic Knee System
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 Received2015-11-17
Decision Date2015-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814703012549 K153310 000
00814703016691 K153310 000

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