K240846

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

510(k) number: K240846
Device name: 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. IL
Product code: NKB — Thoracolumbosacral Pedicle Screw System
Decision date: 2024-04-25
Date received: 2024-03-27
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Orthopedic

PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain

Also available from FDA: K240846.pdf

Official FDA record: K240846

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.