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FDA 510(k)

CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®

K-Number: K182375 · 2019-04-08

ApplicantGlobus Medical, Inc.
Decision Date2019-04-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-04-08 under approval number K182375. 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 CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®?

CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® is a medical device that received FDA 510(k) clearance on 2019-04-08. It is manufactured by Globus Medical, Inc.. The 510(k) number is K182375.

When was CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® approved by the FDA?

CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® received FDA 510(k) clearance on 2019-04-08, under approval number K182375.

What company makes CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®?

CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® is manufactured by Globus Medical, Inc..

What is the FDA product code for CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®?

The FDA product code for CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® is NKB.

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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: 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)

Other Devices by Globus Medical, Inc.

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Related Devices (Code: NKB)

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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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