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)

Zeta Cranial Navigation System

K-Number: K230661 · 2023-09-08

ApplicantZeta Surgical
Decision Date2023-09-08
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Zeta Cranial Navigation System is a medical device manufactured by Zeta Surgical. It received FDA 510(k) clearance on 2023-09-08 under approval number K230661. 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?

Zeta Cranial Navigation System is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Zeta Surgical. The 510(k) number is K230661.

When was Zeta Cranial Navigation System approved by the FDA?

Zeta Cranial Navigation System received FDA 510(k) clearance on 2023-09-08, under approval number K230661.

What company makes Zeta Cranial Navigation System?

Zeta Cranial Navigation System is manufactured by Zeta Surgical.

What is the FDA product code for Zeta Cranial Navigation System?

The FDA product code for Zeta Cranial Navigation System 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)

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.

↑