Piccolo Composite Proximal Tibia 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 Proximal Tibia Plate System.

Pre-market Notification Details

Device IDK201917
510k NumberK201917
Device Name:Piccolo Composite Proximal Tibia Plate System
ClassificationPlate, Fixation, Bone
Applicant CarboFix Orthopedics, Ltd. 11 Ha’hoshlim St Herzeliya,  IL 4672411
ContactYael Rubin
CorrespondentYael Rubin
CarboFix Orthopedics, Ltd. 11 Ha’hoshlim St Herzeliya,  IL 4672411
Product CodeHRS  
Subsequent Product CodeHWC
Subsequent Product CodeKTT
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-10
Decision Date2020-10-08

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