510(k) K253663
- Device
- Zeta Navigation System
- Applicant
- Zeta Surgical, Inc.
- 510(k) number
- K253663
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-01
- Date received
- 2025-11-20
- Regulation
- 882.4560
- Classification name
- Neurological Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Hieu Le Mau
- Address
- 280 Summer St. Floor 7 Boston MA US 02210 02210
FDA Registration Numbers
- 1450662
- 3002807090
- 3015536273
- 3014967969
- 3005180920
- 1061124
- 3013176080
- 3006639944
- 3033536255
- 3021008900
- 3004727093
- 2134470
- 8010871
- 8040537
- 3004464325
- 2031917
- 3009185973
- 3015453963
- 2183744
- 3010041430
- 3023852420
- 1834331
- 1226188
- 3002808157
- 2183671
- 1018470
- 3012352782
- 3010197224
- 1833920
- 3018708317
- 3025603301
- 3012469182
- 3015232217
- 3005061536
- 3004753785
- 3005075696
- 2031093
- 3014170143
- 3004142400
- 1643264
- 3011050570
- 1043653
- 3021591288
- 3013557562
- 3010209365
- 1526439
- 3010202439
- 1219655
- 2133772
- 1123169
- 9610612
- 3010370554
- 3009293341
- 3010032903
- 1721676
- 3008738628
- 3010120104
- 3010363476
- 3028006458
- 3022310762
- 1625507
- 3023194190
- 3017210488
- 3017636737
- 3010123172
- 3009538961
- 1045254
- 9612277
- 9611612
- 3010009632
- 9611390
- 3013302242
- 8030128
- 8010177
- 3010822102
- 3011874573
- 9613350
- 3030733800
- 2424366
Source Documents
Other 510(k) Records For Product Code HAW
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026-03-26 |
| K231897 | NeuroAlign software | Medivis, Inc. | 2025-10-21 |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | 2025-09-05 |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025-09-04 |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | 2025-07-09 |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | 2025-02-05 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG | 2025-01-28 |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025-01-24 |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025-01-17 |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | 2024-12-27 |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-10-04 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | 2024-01-12 |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | 2024-01-12 |