HAW · Neurological Stereotaxic Instrument

Device class

Class II

Regulation 882.4560

Total clearances

2020-02-13 → 2026-09-10

Last 12 months

Unique sponsors

Classification details

Medical specialty

Neurology

Review panel

Regulation number

882.4560

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
ClearPoint Neuro, Inc.	10	0	2025-01-24
Brainlab AG	9	0	2025-01-28
Medtronic Navigation	6	1	2026-03-26
Zeta Surgical, Inc.	4	1	2026-05-01
Navinetics, Inc.	2	0	2023-07-14
Koh Young Technology, Inc.	2	1	2026-09-10
PAJUNK GmbH Medizintechnologie	2	0	2023-02-22
Medtech S.A.S	2	0	2023-07-20
Intravent Medical Partners	1	0	2025-09-05
Medtech S.A	1	0	2020-05-29
Sinovation (Beijing) Medical Technology Co., Ltd.	1	0	2023-06-18
Stryker Corporation	1	0	2023-02-16
Mri Interventions, Inc.	1	0	2020-02-13
Intravent Medical Partners, LP	1	0	2021-08-27
Soterix Medical, Inc.	1	0	2020-04-06
Bayer Medical Care, Inc.	1	0	2025-09-04
Eemagine Medical Imaging Solutions GmbH	1	0	2022-04-08
Phasor Health, LLC	1	0	2025-07-09
Localite GmbH	1	0	2023-04-17
Tonica Elektronik A/S	1	0	2023-03-17
Brain Navi Biotechnology Co., Ltd.	1	0	2025-05-23
Claronav	1	0	2025-02-05
Medivis, Inc.	1	1	2025-10-21
Therataxis, LLC	1	0	2021-12-03
7D Surgical ULC	1	0	2024-12-27

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
61796	CPT	—	High	Stereotactic procedures include frame application and navigation
61797	CPT	—	Medium	Stereotactic biopsy with imaging guidance

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-10	K253856	Koh Young Technology, Inc.	Geniant Cranial (Navigated Neurosurgical Positioning Robot)
2026-08-05	K261932	Elekta Solutions AB	Leksell® Vantage Stereotactic System
2026-05-01	K253663	Zeta Surgical, Inc.	Zeta Navigation System
2026-03-26	K253379	Medtronic Navigation, Inc.	Stealth AXiS Cranial clinical application
2025-10-21	K231897	Medivis, Inc.	NeuroAlign software
2025-09-05	K251317	Intravent Medical Partners	SOLOPASS 2.0 System
2025-09-04	K250893	Bayer Medical Care, Inc.	Ball Joint Guide Array (66295)
2025-07-09	K250505	Phasor Health, LLC	EZ-FIDUCIALS
2025-05-23	K242575	Brain Navi Biotechnology Co., Ltd.	Stereotaxic Guiding Surgical Devices, NaoTrac S
2025-02-05	K241327	Claronav	Navient Image Guide Navigation System (955-NC-NC), Cranial
2025-01-28	K243698	Brainlab AG	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
2025-01-24	K243657	ClearPoint Neuro, Inc.	ClearPoint System (Software Version 3.0)
2025-01-17	K241333	Koh Young Technology, Inc.	Geniant Cranial (Navigated Neurosurgical Positioning Robot)
2024-12-27	K242480	7D Surgical ULC	FLASH EVD System (10-0002)
2024-10-04	K242351	Zeta Surgical, Inc.	Zeta Cranial Navigation System (ZNS131-US)
2024-04-26	K233703	ClearPoint Neuro, Inc.	Bone Anchor (NGS-BA-01)
2024-01-12	K233155	ClearPoint Neuro, Inc.	ClearPointer Optical Navigation Wand
2024-01-12	K233144	ClearPoint Neuro, Inc.	ClearPoint Bone Screw Fiducials
2024-01-12	K233141	ClearPoint Neuro, Inc.	SmartFrame OR
2024-01-10	K233903	Zeta Surgical, Inc.	Zeta Cranial Navigation System (ZNS131-US)
2023-11-27	K233243	ClearPoint Neuro, Inc.	ClearPoint System (Software Version 2.2)
2023-10-19	K231976	Medtronic Navigation, Inc.	StealthStation Cranial Software, v3.1.5 (9735585)
2023-09-15	K232102	ClearPoint Neuro, Inc.	ClearPoint Array System (Version 1.2)
2023-09-09	K223864	Brainlab AG	Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
2023-09-08	K230661	Zeta Surgical	Zeta Cranial Navigation System