CalcaNail Orthopedic Nail

Rod, Fixation, Intramedullary And Accessories

Fournitures Hospitalieres Industrie

The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Calcanail Orthopedic Nail.

Pre-market Notification Details

Device IDK150463
510k NumberK150463
Device Name:CalcaNail Orthopedic Nail
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Fournitures Hospitalieres Industrie ZI De Kernevez – 6 Rue Nobel Quimper,  FR 29000
ContactPatricia Donnard
CorrespondentPatricia Donnard
Fournitures Hospitalieres Industrie ZI De Kernevez ? 6 Rue Nobel Quimper,  FR 29000
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-23
Decision Date2015-05-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03661489693168 K150463 000
03661489693151 K150463 000

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