CarboClear® Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Carbofix Orthopedics Ltd.

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

Pre-market Notification Details

Device IDK200883
510k NumberK200883
Device Name:CarboClear® Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
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 CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-02
Decision Date2020-06-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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Trademark Results [CarboClear]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARBOCLEAR
CARBOCLEAR
86654176 5283412 Live/Registered
CarboFix In Orthopedics LLC
2015-06-07

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