CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System— 510(k) K254045

Name: FDA 510(k) clearance K254045
Creator: U.S. Food and Drug Administration
Published: 2026-03-16

Substantially Equivalent

CarboFix Orthopedics , Ltd.

FDA 510(k) clearance K254045 for CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System, Substantially Equivalent on 2026-03-16. Applicant: CarboFix Orthopedics , Ltd.. Device class: 2.

Summary

CarboFix Orthopedics' record covers the CarboClear® Posterior Cervical Screw System and the CarboClear® Hybrid Posterior Cervical Screw System. Both are filed under NKG, posterior cervical screw systems.

Class II, 21 CFR 888.3075. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

CarboFix Orthopedics filed from Herzeliya, Israel. The decision came 89 calendar days after receipt (December 17, 2025 to March 16, 2026).

Clearance details

Applicant: CarboFix Orthopedics , Ltd.
Product code: Product code NKG
Device class: Class 2
Regulation: 21 CFR 888.3075
Advisory panel: Orthopedic
Date received: 2025-12-17
Decision date: 2026-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzeliya, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKG

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K254260 — The VEGA Cervical Screw System2026-09-17
K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
K254165 — Infinity OCT System2026-01-21
K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments2025-11-12
K253129 — Infinity OCT System2025-10-24

More clearances from CarboFix Orthopedics , Ltd.

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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
K233989 — CarboClear® Posterior Cervical Screw System2024-03-27
K233944 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments2024-01-10

Adverse events under product code NKG

product code NKG

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.