Product code HAW
- Device name
- Neurological Stereotaxic Instrument
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4560
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 |
| 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 |
| K233141 | SmartFrame OR | ClearPoint Neuro, Inc. | 2024-01-12 |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-01-10 |
| K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | 2023-11-27 |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | 2023-10-19 |
| K232102 | ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. | 2023-09-15 |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Brainlab AG | 2023-09-09 |
| K230661 | Zeta Cranial Navigation System | Zeta Surgical | 2023-09-08 |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG | 2023-07-21 |
| K231103 | ROSA ONE Brain Application | Medtech S.A.S | 2023-07-20 |
| K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Navinetics, Inc. | 2023-07-14 |
| K220072 | Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd. | 2023-06-18 |
| K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab AG | 2023-04-19 |
| K223577 | Localite TMS Navigator TS | Localite GmbH | 2023-04-17 |
| K221544 | MagVenture TMS Atlas Neuro Navigation System | Tonica Elektronik A/S | 2023-03-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08720892330833 | Ball Joint Guide Array (BJGA)-Guide Set | Bayer Medical Care B.V. | 2026-04-24 |
| 08720892330826 | Ball Joint Guide Array (BJGA)-Navigation Set | Bayer Medical Care B.V. | 2026-04-24 |
| G076A012355A1 | Localite TMS Navigator TS | LOCALITE GmbH | 2023-07-05 |
| G076A012354A1 | Localite TMS Navigator TS | LOCALITE GmbH | 2023-07-05 |
| 07613327499711 | N/A | Stryker Leibinger GmbH & Co. KG | 2023-03-23 |
| 07613327500516 | N/A | Stryker Leibinger GmbH & Co. KG | 2022-07-22 |
| 07613327500561 | N/A | Stryker Leibinger GmbH & Co. KG | 2022-07-22 |
| 07613327500578 | N/A | Stryker Leibinger GmbH & Co. KG | 2022-07-22 |
| 07613327503265 | N/A | Stryker Leibinger GmbH & Co. KG | 2022-07-22 |
| 07613327413076 | n/a | Stryker Leibinger GmbH & Co. KG | 2018-08-08 |
| 07613327413205 | n/a | Stryker Leibinger GmbH & Co. KG | 2018-08-08 |
| 07613327413090 | n/a | Stryker Leibinger GmbH & Co. KG | 2018-08-08 |
| 10381780167334 | CRW® | INTEGRA LIFESCIENCES CORPORATION | 2017-04-14 |
| 07613327097627 | CranialMask Tracker | Stryker Leibinger GmbH & Co. KG | 2017-03-13 |
| 10381780167327 | CRW® | INTEGRA LIFESCIENCES CORPORATION | 2016-09-19 |
| 10381780251453 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251446 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251439 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251422 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251415 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251408 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251392 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251385 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251378 | CRW® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251361 | CRW® Precision | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251354 | CRW® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251347 | CRW® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780251330 | CRW® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780210870 | CRW® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780210856 | CRW® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |