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FDA 510(k)

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS

K-Number: K203153 · 2021-01-19

ApplicantGlobus Medical, Inc.
Decision Date2021-01-19
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 2021-01-19 under approval number K203153. 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 2021-01-19. It is manufactured by Globus Medical, Inc.. The 510(k) number is K203153.

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

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS received FDA 510(k) clearance on 2021-01-19, under approval number K203153.

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.

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: 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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