# Zeta Surgical, Inc.

- Location (FDA's records): Boston, MA
- FDA decisions: 6 (2023–2026): 6 510(k) clearances
- Names in FDA's records: Zeta Surgical, Inc. (5); Zeta Surgical (1)
- Product codes: HAW (4), SGE (1), QFF (1)
- 510(k) review time since 2016: median 110 days, against 125 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 7D Surgical, Inc.: 1 (https://510kreport.com/company/7d-surgical)
- Localite GmbH: 1 (https://510kreport.com/company/localite)
- Medtronic Surgical Navigation Technologies: 1 (https://510kreport.com/company/medtronic-surgical-navigation-technologies)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)
- Axilum Robotics: 1 (https://510kreport.com/company/axilum-robotics)

## Its most-cited devices
- K230661: Zeta Cranial Navigation System (2023), cited by 1
- K233903: Zeta Cranial Navigation System (ZNS131-US) (2024), cited by 1
- K251927: Zeta Navigation System (ZNS131-US) (2025), cited by 1
- K242351: Zeta Cranial Navigation System (ZNS131-US) (2024), cited by 1

## Recent decisions
- K261471: Zeta TMS Navigation System (Jul 9, 2026)
- K253663: Zeta Navigation System (May 1, 2026)
- K251927: Zeta Navigation System (ZNS131-US) (Oct 10, 2025)
- K242351: Zeta Cranial Navigation System (ZNS131-US) (Oct 4, 2024)
- K233903: Zeta Cranial Navigation System (ZNS131-US) (Jan 10, 2024)
- K230661: Zeta Cranial Navigation System (Sep 8, 2023)

Source page: https://510kreport.com/company/zeta-surgical