SPINEART Navigation Instrument System

Orthopedic Stereotaxic Instrument

Spineart SA

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

Pre-market Notification Details

Device IDK183630
510k NumberK183630
Device Name:SPINEART Navigation Instrument System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Spineart SA Chemin Du Pre- Fleuri 3 Plan-les-ouates,  CH 1228
ContactFranck Pennesi
CorrespondentMeredith Lee May
Empirical Consulting LLC 4628 Northpark Dr Colorado Springs,  CO  80918
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-06-10

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