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510(k) K233903

Zeta Cranial Navigation System (ZNS131-US) by Zeta Surgical, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2024
Date Received
December 11, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Zeta Surgical, Inc.

  • K251927 — Zeta Navigation System (ZNS131-US) (October 10, 2025)
  • K242351 — Zeta Cranial Navigation System (ZNS131-US) (October 4, 2024)
  • K230661 — Zeta Cranial Navigation System (September 8, 2023)

Other clearances for product code HAW

  • K231897 — NeuroAlign software (October 21, 2025)
  • K251317 — SOLOPASS 2.0 System (September 5, 2025)
  • K250893 — Ball Joint Guide Array (66295) (September 4, 2025)
  • K250505 — EZ-FIDUCIALS (July 9, 2025)
  • K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S (May 23, 2025)
  • K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial (February 5, 2025)
  • K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm (January 28, 2025)
  • K243657 — ClearPoint System (Software Version 3.0) (January 24, 2025)
  • K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) (January 17, 2025)
  • K242480 — FLASH EVD System (10-0002) (December 27, 2024)