FDA 510(k)

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments

K-Number: K231850 · 2024-03-14

Decision Date2024-03-14

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-03-14 under approval number K231850. 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 ExcelsiusGPS® Instruments?

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments is a medical device that received FDA 510(k) clearance on 2024-03-14. It is manufactured by Globus Medical, Inc.. The 510(k) number is K231850.

When was QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments approved by the FDA?

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments received FDA 510(k) clearance on 2024-03-14, under approval number K231850.

What company makes QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments?

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

What is the FDA product code for QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments?

The FDA product code for QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments is NKG.

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Related PubMed Literature

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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

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