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FDA 510(k)

CarboClear® Hybrid Pedicle Screw System

K-Number: K243106 · 2024-11-05

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2024-11-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarboClear® Hybrid Pedicle Screw System is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2024-11-05 under approval number K243106. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarboClear® Hybrid Pedicle Screw System?

CarboClear® Hybrid Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-11-05. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K243106.

When was CarboClear® Hybrid Pedicle Screw System approved by the FDA?

CarboClear® Hybrid Pedicle Screw System received FDA 510(k) clearance on 2024-11-05, under approval number K243106.

What company makes CarboClear® Hybrid Pedicle Screw System?

CarboClear® Hybrid Pedicle Screw System is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for CarboClear® Hybrid Pedicle Screw System?

The FDA product code for CarboClear® Hybrid Pedicle Screw System is NKB.

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Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by CarboFix Orthopedics , Ltd.

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Related Devices (Code: NKB)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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