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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-04-08 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K182375.

When did CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® receive FDA 510(k) clearance?

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

Who is the listed applicant for CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®?

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 CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®?

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

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Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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