Piccolo Composite(R) Distal Volar Radius 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(r) Distal Volar Radius Plate System.

Pre-market Notification Details

Device IDK160002
510k NumberK160002
Device Name:Piccolo Composite(R) Distal Volar Radius Plate System
ClassificationPlate, Fixation, Bone
Applicant CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya,  IL 4672411
ContactYael Rubin
CorrespondentYael Rubin
CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya,  IL 4672411
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-04
Decision Date2016-03-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109339931 K160002 000
07290109337319 K160002 000
07290109337326 K160002 000
07290109337333 K160002 000
07290109337340 K160002 000
07290109337357 K160002 000
07290109339771 K160002 000
07290109339788 K160002 000
07290109339924 K160002 000
07290109337302 K160002 000

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