Modus Nav
510(k) K183325
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183325 | Date14 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K183325
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HAW
- FDA applicant
- Synaptive Medical, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Modus Nav is a Computer-Assisted Surgical Navigation System (HAW classification) designed to provide real-time, image-guided visualization for neurosurgical procedures. It integrates with imaging data to assist surgeons in planning and executing precise trajectories, enhancing spatial orientation during cranial and spinal interventions.
This system is intended for use in operating rooms and is supplied as a reusable, modular unit requiring installation and maintenance by qualified service personnel. It is not single-use and must comply with MRI safety standards as specified by the manufacturer. Authorized in the U.S. via FDA 510(k) clearance (K183325), it operates under traditional review with a Neurology advisory committee designation.
Devices cleared under K183325
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BrightMatter Guide Calibration Block SYN-0014 | SYN-0014 | 00670082000023 | On the market | |
| BrightMatter Patient Reference SYN-0021 | SYN-0021 | 00670082000047 | On the market | |
| BrightMatter Pointer Sterilizable Storage Tray SYN-0596 | SYN-0596 | 00670082000108 | On the market | |
| BrightMatter Pointer SYN-0642 | SYN-0642 | 00670082000092 | On the market | |
| Long Pointer SYN-0975 | SYN-0975 | 00670082000535 | On the market | |
| Modus Nav Operator Cart SYN-0982 | SYN-0982 | 00670082000528 | On the market | |
| Modus Nav Software 2.1 | SYN-0867 / 2.1 | 00670082000504 | On the market | |
| Modus Nav Software 2.2 | SYN-0867 / 2.2 | 00670082000627 | On the market | |
| Multi-Tool Calibration Device SYN-0755 | SYN-0755 | 00670082000252 | On the market | |
| Short Pointer SYN-0559 | SYN-0559 | 00670082000269 | On the market | |
| Sterilizable Storage Tray SYN-0754 | SYN-0754 | 00670082000351 | On the market | |
| Tracking Array for Brainpath SYN-0015 | SYN-0015 | 00670082000030 | On the market |
Similar devices
Other devices filed under FDA product code HAW (Neurological Stereotaxic Instrument).
- SELF ADHERING NAVIGUS GUIDE by Image-Guided Neurologics, Inc.
- STEALTHSTATION SYSTEM UPDATE by Medtronic Surgical Navigation Technologies
- KNEE MODULE FOR THE STEALTHSTATION SYSTEM by Medtronic Surgical Navigation Technologies
- NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 by Orthosoft Inc
- MDT Navigable Brain Biopsy Cannula by IZI MEDICAL PRODUCTS LLC
- Leksell Vantage Stereotactic System 1040015 1040031 by Elekta Solutions AB
- NBD HEAD SCREW by New Business Development, LLC
- CRANIAL IMAGE GUIDED SURGERY SYSTEM by Brainlab AG
- SOLERA 9735469 by Medtronic Navigation Inc.
- 9733214 by Medtronic Navigation Inc.