ExactechGPS System

Orthopedic Stereotaxic Instrument

Blue Ortho

The following data is part of a premarket notification filed by Blue Ortho with the FDA for Exactechgps System.

Pre-market Notification Details

Device IDK193618
510k NumberK193618
Device Name:ExactechGPS System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Blue Ortho 6 Allee De Bethleem Gieres,  FR 38610
ContactMatthieu Coic
CorrespondentMatthieu Coic
Blue Ortho 6 Allee De Bethleem Gieres,  FR 38610
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-09-02

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