SPINEART Navigation Instrument System

Orthopedic Stereotaxic Instrument

Spineart

The following data is part of a premarket notification filed by Spineart with the FDA for Spineart Navigation Instrument System.

Pre-market Notification Details

Device IDK210472
510k NumberK210472
Device Name:SPINEART Navigation Instrument System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Spineart 3 Chemin Du Pré Fleuri Plan Les Ouates,  CH 1228
ContactFranck Pennesi
CorrespondentFranck Pennesi
Spineart 3 Chemin Du Pré Fleuri Plan Les Ouates,  CH 1228
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-17
Decision Date2021-03-19

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