Materialise Glenoid Positioning System

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Materialise NV

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

Pre-market Notification Details

Device IDK170893
510k NumberK170893
Device Name:Materialise Glenoid Positioning System
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant Materialise NV Technologielaan 15 Leuven,  BE 3001
ContactOliver Clemens
CorrespondentOliver Clemens
Materialise NV Technologielaan 15 Leuven,  BE 3001
Product CodeKWS  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-27
Decision Date2017-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E314804070220 K170893 000

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