Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-08-06 under approval 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. It is manufactured by Globus Medical, Inc.. The 510(k) number is K191835.

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

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

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

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

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.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07596550 Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy NOT_YET_RECRUITING NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING

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

View all 91 devices →

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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.

↑