SYMMETRIC TOTAL KNEE SYSTEM

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

SIGNAL MEDICAL CORPORATION

The following data is part of a premarket notification filed by Signal Medical Corporation with the FDA for Symmetric Total Knee System.

Pre-market Notification Details

Device IDK080199
510k NumberK080199
Device Name:SYMMETRIC TOTAL KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant SIGNAL MEDICAL CORPORATION 1000 DES PERES RD. SUITE 140 St. Louis,  MO  63131
ContactBrian Katerberg
CorrespondentBrian Katerberg
SIGNAL MEDICAL CORPORATION 1000 DES PERES RD. SUITE 140 St. Louis,  MO  63131
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-25
Decision Date2008-07-03
Summary:summary

NIH GUDID Devices

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