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FDA 510(k)

Zeta Navigation System

K-Number: K253663 · 2026-05-01

ApplicantZeta Surgical, Inc.
Decision Date2026-05-01
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Zeta Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zeta Surgical, Inc.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K253663. 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 Navigation System?

Zeta Navigation System is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Zeta Surgical, Inc.. The 510(k) number is K253663.

When did Zeta Navigation System receive FDA 510(k) clearance?

Zeta Navigation System received FDA 510(k) clearance on 2026-05-01, under 510(k) number K253663.

Who is the listed applicant for Zeta Navigation System?

The FDA 510(k) record lists Zeta Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zeta Navigation System?

The FDA product code for Zeta Navigation System is HAW.

Other records listing Zeta Surgical, Inc. as applicant

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.

K261471Zeta TMS Navigation SystemK251927Zeta Navigation System (ZNS131-US)K242351Zeta Cranial Navigation System (ZNS131-US)K233903Zeta Cranial Navigation System (ZNS131-US)K230661Zeta Cranial Navigation System

Related Devices (Code: HAW)

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.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.K250505EZ-FIDUCIALSPhasor Health, LLC

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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