Materialise Shoulder Guide And Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner

Shoulder Arthroplasty Implantation System

Materialise NV

The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Shoulder Guide And Models, Materialise Surgicase Shoulder Planner, Materialise Shoulder Planner, Surgicase Shoulder Planner, Surgicase Planner.

Pre-market Notification Details

Device IDK193560
510k NumberK193560
Device Name:Materialise Shoulder Guide And Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner
ClassificationShoulder Arthroplasty Implantation System
Applicant Materialise NV Technologielaan 15 Leuven,  BE 3001
ContactVeerle Vanderheyden
CorrespondentVeerle Vanderheyden
Materialise NV Technologielaan 15 Leuven,  BE 3001
Product CodeQHE  
Subsequent Product CodeKWS
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-03-20

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