Materialise PKA Guide System

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

Materialise NV

The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Pka Guide System.

Pre-market Notification Details

Device IDK202207
510k NumberK202207
Device Name:Materialise PKA Guide System
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Materialise NV Technologielaan 15 Leuven,  BE 3001
ContactVeerle Vanderheyden
CorrespondentVeerle Vanderheyden
Materialise NV Technologielaan 15 Leuven,  BE 3001
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-06
Decision Date2020-10-02

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