CarboClear Lumbar Cage System

Intervertebral Fusion Device With Bone Graft, Lumbar

CarboFix Orthopedics Ltd.

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

Pre-market Notification Details

Device IDK193378
510k NumberK193378
Device Name:CarboClear Lumbar Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya,  IL 4672411
ContactHila Wachsler-avrahami
CorrespondentHila Wachsler-avrahami
CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya,  IL 4672411
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-05
Decision Date2020-03-02

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