PICCOLO COMPOSITE PLATE SYSTEM

Plate, Fixation, Bone

CARBOFIX ORTHOPEDICS LTD.

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

Pre-market Notification Details

Device IDK120409
510k NumberK120409
Device Name:PICCOLO COMPOSITE PLATE SYSTEM
ClassificationPlate, Fixation, Bone
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 CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-09
Decision Date2012-11-26
Summary:summary

NIH GUDID Devices

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