AUTOBAHN(R) EVO Femoral Nails

Rod, Fixation, Intramedullary And Accessories

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Autobahn(r) Evo Femoral Nails.

Pre-market Notification Details

Device IDK220659
510k NumberK220659
Device Name:AUTOBAHN(R) EVO Femoral Nails
ClassificationRod, Fixation, Intramedullary And Accessories
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 CodeHSB  
Subsequent Product CodeHWC
Subsequent Product CodeJDS
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-07
Decision Date2022-09-09

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