CarboClear® Hybrid Pedicle Screw System +3 more— 510(k) K240846

Clearance details

Device name as filed

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.

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2024-03-27

Decision date

2024-04-25

Decision

Substantially Equivalent

Clearance type

Special

Location

Herzeliya, IL

• K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-09-04
• K253943 — Tiger 2 System2026-07-24
• K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)2026-07-24
• K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System2026-07-14
• K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-07-01

• K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System2026-03-16
• K243106 — CarboClear® Hybrid Pedicle Screw System2024-11-05
• K233793 — CarboClear® X Pedicle Screw System2024-08-01
• K233989 — CarboClear® Posterior Cervical Screw System2024-03-27
• K233944 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments2024-01-10

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →