Zeta Cranial Navigation System (ZNS131-US)— 510(k) K233903

Name: FDA 510(k) clearance K233903
Creator: U.S. Food and Drug Administration
Published: 2024-01-10

Substantially Equivalent

Zeta Surgical, Inc.

FDA 510(k) clearance K233903 for Zeta Cranial Navigation System (ZNS131-US), Substantially Equivalent on 2024-01-10. Applicant: Zeta Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Zeta Surgical, Inc.
Product code: Code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2023-12-11
Decision date: 2024-01-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAW

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K261932 — Leksell® Vantage Stereotactic System2026-08-05
K253663 — Zeta Navigation System2026-05-01
K253379 — Stealth AXiS Cranial clinical application2026-03-26
K231897 — NeuroAlign software2025-10-21
K251317 — SOLOPASS 2.0 System2025-09-05

More clearances from Zeta Surgical, Inc.

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K261471 — Zeta TMS Navigation System2026-07-09
K251927 — Zeta Navigation System (ZNS131-US)2025-10-10
K242351 — Zeta Cranial Navigation System (ZNS131-US)2024-10-04

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.