FDA.reportPublic FDA data

510(k) K240846

Device
CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
Applicant
CarboFix Orthopedics , Ltd.
510(k) number
K240846
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-25
Date received
2024-03-27
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hila Wachsler-Avrahami
Address
11 Ha'Hoshlim St. Herzeliya IL 4672411 4672411

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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