ExcelsiusGPS Cranial 1.0 Module

Orthopedic Stereotaxic Instrument

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Excelsiusgps Cranial 1.0 Module.

Pre-market Notification Details

Device IDK200047
510k NumberK200047
Device Name:ExcelsiusGPS Cranial 1.0 Module
ClassificationOrthopedic Stereotaxic Instrument
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactJennifer Antonacci
CorrespondentJennifer Antonacci
Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-09
Decision Date2020-07-10

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