Orthofix MJ-FLEX THE NEW METAIZEAU NAIL

Pin, Fixation, Smooth

Orthofix Srl

The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Mj-flex The New Metaizeau Nail.

Pre-market Notification Details

Device IDK173051
510k NumberK173051
Device Name:Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
ClassificationPin, Fixation, Smooth
Applicant Orthofix Srl Via Delle Nazioni 9 Bussolengo,  IT 37012
ContactGianluca Ricadona
CorrespondentChery Wagoner
Wagoner Consulting LLC PO Box 15729 Wilmington,  NC  24408
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-28
Decision Date2017-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18054242518839 K173051 000
18054242518730 K173051 000
18054242518747 K173051 000
18054242518754 K173051 000
18054242518761 K173051 000
18054242518778 K173051 000
18054242518785 K173051 000
18054242518792 K173051 000
18054242518808 K173051 000
18054242518815 K173051 000
18054242518822 K173051 000
18054242518723 K173051 000

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