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FDA 510(k)

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments

K-Number: K191835 · 2019-08-06

ApplicantGlobus Medical, Inc.
Decision Date2019-08-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS 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 2019-08-06 under 510(k) number K191835. 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 Instruments?

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Globus Medical, Inc.. The 510(k) number is K191835.

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

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments received FDA 510(k) clearance on 2019-08-06, under 510(k) number K191835.

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

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