Orthofix True Lok Hexapod System VI.3

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 Orthofix True Lok Hexapod System Vi.3.

Pre-market Notification Details

Device IDK143125
510k NumberK143125
Device Name:Orthofix True Lok Hexapod System VI.3
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant Orthofix Srl Via Delle Nazioni 9 Verona (bussolengo),  IT 37012
ContactGianluca Ricadona
CorrespondentCherly Wagoner
Wagoner Consulting LLC PO Box 15729 Wilmington,  NC  28408
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-31
Decision Date2014-12-10
Summary:summary

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