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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2021-08-18 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K211957.

When did QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: NKG)

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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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