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FDA 510(k)

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System

K-Number: K254045 · 2026-03-16

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2026-03-16
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2026-03-16 under approval number K254045. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System?

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K254045.

When was CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System approved by the FDA?

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System received FDA 510(k) clearance on 2026-03-16, under approval number K254045.

What company makes CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System?

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System?

The FDA product code for CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System is NKG.

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Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

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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