Modus Nav
FDA 510(k) K183325 · Synaptive Medical, Inc.
510(k) numberK183325
Submission
- Device name
- Modus Nav
- Applicant
- Synaptive Medical, Inc.
Toronto, CA - Received
- November 30, 2018
- Decision date
- July 14, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K231986 | Modus IRIZI · Traditional | 03/25/2024SE |
| K232981 | Synq Software Version 1.3LNH · Traditional | 10/11/2023SE |
| K200327 | EvryLNH · Traditional | 04/29/2020SE |
| K180394 | BrightMatter Plan 1.6.0LLZ · Traditional | 03/09/2018SE |
| K160523 | BrightMatter Guide with BrightMatter PointerHAW · Traditional | 06/24/2016SE |
| K153281 | BrightMatter Guide with Surface Trace RegistrationHAW · Traditional | 03/30/2016SE |
| K153284 | Synaptive ImageDrive ProLLZ · Traditional | 03/29/2016SE |
| K142024 | Brightmatter Navigation SystemHAW · Traditional | 04/02/2015SE |
| K140337 | Brightmatter Planning SoftwareLLZ · Traditional | 06/02/2014SE |
Questions and answers
When was Modus Nav cleared by the FDA?
Modus Nav (K183325) received a 510(k) decision of Substantially Equivalent on July 14, 2019, 226 days after the submission was received.
What is the product code of K183325?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.