TrueLok Evo

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

Orthofix SRL

The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Truelok Evo.

Pre-market Notification Details

Device IDK212044
510k NumberK212044
Device Name:TrueLok Evo
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant Orthofix SRL Via Delle Nazioni, 9 Bussolengo,  IT 37012
ContactGianluca Ricadona
CorrespondentCheryl Wagoner
Wagoner Consulting LLG PO Box 15729 Wilmington,  NC  28408
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-30
Decision Date2021-11-05

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