MEDIAL ROTATION KNEE SYSTEM

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

ENGINEERING CONSULTING SERVICES, INC.

The following data is part of a premarket notification filed by Engineering Consulting Services, Inc. with the FDA for Medial Rotation Knee System.

Pre-market Notification Details

Device IDK020214
510k NumberK020214
Device Name:MEDIAL ROTATION KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant ENGINEERING CONSULTING SERVICES, INC. 3150 E. 200TH ST. Prior Lake,  MN  55372
ContactAl Lippincott
CorrespondentAl Lippincott
ENGINEERING CONSULTING SERVICES, INC. 3150 E. 200TH ST. Prior Lake,  MN  55372
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-22
Decision Date2002-02-26
Summary:summary

NIH GUDID Devices

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