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 IDK170401
510k NumberK170401
Device Name:Piccolo Composite® 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  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-09
Decision Date2017-05-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290110202262 K170401 000
07290110201227 K170401 000
07290110201210 K170401 000
07290110201203 K170401 000
07290110201074 K170401 000
07290110201067 K170401 000
07290110201050 K170401 000
07290110201043 K170401 000
07290110201036 K170401 000
07290110201029 K170401 000
07290110201012 K170401 000
07290110201005 K170401 000
07290110201234 K170401 000
07290110201241 K170401 000
07290110201708 K170401 000
07290110201692 K170401 000
07290110201630 K170401 000
07290110201623 K170401 000
07290110201487 K170401 000
07290110201425 K170401 000
07290110201296 K170401 000
07290110201289 K170401 000
07290110201272 K170401 000
07290110201265 K170401 000
07290110201258 K170401 000
07290110200992 K170401 000

Trademark Results [Piccolo Composite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PICCOLO COMPOSITE
PICCOLO COMPOSITE
85024876 4068081 Live/Registered
CARBOFIX ORTHOPEDICS LTD.
2010-04-28

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