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FDA 510(k)

QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments

K-Number: K211957 · 2021-08-18

ApplicantGlobus Medical, Inc.
Decision Date2021-08-18
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2021-08-18 under approval number K211957. 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 QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is a medical device that received FDA 510(k) clearance on 2021-08-18. It is manufactured by Globus Medical, Inc.. The 510(k) number is K211957.

When was QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments approved by the FDA?

QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments received FDA 510(k) clearance on 2021-08-18, under approval number K211957.

What company makes QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is manufactured by Globus Medical, Inc..

What is the FDA product code for QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

The FDA product code for QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is NKG.

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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: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

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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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