High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

Bone Cement, Posterior Screw Augmentation

CarboFix Orthopedics Ltd.

The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for High V+ Bone Cement, Carboclear® Fenestrated Pedicle Screws.

Pre-market Notification Details

Device IDK190526
510k NumberK190526
Device Name:High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
ClassificationBone Cement, Posterior Screw Augmentation
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 CodePML  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-04
Decision Date2019-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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