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FDA 510(k)

Zeta Cranial Navigation System (ZNS131-US)

K-Number: K233903 · 2024-01-10

ApplicantZeta Surgical, Inc.
Decision Date2024-01-10
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Zeta Cranial Navigation System (ZNS131-US) is a medical device manufactured by Zeta Surgical, Inc.. It received FDA 510(k) clearance on 2024-01-10 under approval number K233903. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zeta Cranial Navigation System (ZNS131-US)?

Zeta Cranial Navigation System (ZNS131-US) is a medical device that received FDA 510(k) clearance on 2024-01-10. It is manufactured by Zeta Surgical, Inc.. The 510(k) number is K233903.

When was Zeta Cranial Navigation System (ZNS131-US) approved by the FDA?

Zeta Cranial Navigation System (ZNS131-US) received FDA 510(k) clearance on 2024-01-10, under approval number K233903.

What company makes Zeta Cranial Navigation System (ZNS131-US)?

Zeta Cranial Navigation System (ZNS131-US) is manufactured by Zeta Surgical, Inc..

What is the FDA product code for Zeta Cranial Navigation System (ZNS131-US)?

The FDA product code for Zeta Cranial Navigation System (ZNS131-US) is HAW.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT04115033 Randomized Controlled Trial of CES for Fibromyalgia COMPLETED NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Related PubMed Literature

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 Zeta Surgical, Inc.

K242351Zeta Cranial Navigation System (ZNS131-US) K251927Zeta Navigation System (ZNS131-US) K253663Zeta Navigation System

Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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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