SURGICASE GUIDE

Neurological Stereotaxic Instrument

MATERIALISE N.V.

The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Surgicase Guide.

Pre-market Notification Details

Device IDK111558
510k NumberK111558
Device Name:SURGICASE GUIDE
ClassificationNeurological Stereotaxic Instrument
Applicant MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven,  BE 3001
ContactAlexandra Razzhivina
CorrespondentAlexandra Razzhivina
MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven,  BE 3001
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-03
Decision Date2012-03-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05420060351105 K111558 000
05420060351099 K111558 000
05420060351082 K111558 000
05420060350115 K111558 000
05420060350108 K111558 000

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