PICCOLO COMPOSITE NAILING SYSTEM

Rod, Fixation, Intramedullary And Accessories

CARBOFIX ORTHOPEDICS LTD.

The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Piccolo Composite Nailing System.

Pre-market Notification Details

Device IDK111056
510k NumberK111056
Device Name:PICCOLO COMPOSITE NAILING SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya,  IL 46724
ContactYael Rubin
CorrespondentYael Rubin
CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya,  IL 46724
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-18
Decision Date2011-05-03
Summary:summary

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