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FDA 510(k)

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments

K-Number: K210716 · 2021-04-06

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2021-04-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2021-04-06 under approval number K210716. 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 X Pedicle Screw System, CarboClear X Navigated Instruments?

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments is a medical device that received FDA 510(k) clearance on 2021-04-06. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K210716.

When was CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments approved by the FDA?

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments received FDA 510(k) clearance on 2021-04-06, under approval number K210716.

What company makes CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments?

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments?

The FDA product code for CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) 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)

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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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