Symmetric Total Knee System

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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 IDK203779
510k NumberK203779
Device Name:Symmetric Total Knee System
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant Signal Medical Corporation 400 Pyramid Dr. Marysville,  MI  48040
ContactDora Culton
CorrespondentDora Culton
Signal Medical Corporation 400 Pyramid Dr. Marysville,  MI  48040
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-06-10

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