CarboClear® Posterior Cervical Screw System— 510(k) K233989

Clearance details

Applicant

CarboFix Orthopedics , Ltd.

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2023-12-18

Decision date

2024-03-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Herzeliya, IL

• K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
• K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System2026-03-16
• K254165 — Infinity OCT System2026-01-21
• K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments2025-11-12
• K253129 — Infinity OCT System2025-10-24

• K243106 — CarboClear® Hybrid Pedicle Screw System2024-11-05
• K233793 — CarboClear® X Pedicle Screw System2024-08-01
• K240846 — CarboClear® Hybrid Pedicle Screw System +3 more2024-04-25
• K233944 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments2024-01-10
• K232341 — CarboClear® Pedicle Screw System2023-10-10

Death

15

Injury

1,090

Malfunction

529

Total

1,634

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 →