ROSA ONE Brain Application
FDA 510(k) K182417 · Medtech S.A
510(k) numberK182417
Submission
- Device name
- ROSA ONE Brain Application
- Applicant
- Medtech S.A
Montpellier, FR - Received
- September 5, 2018
- Decision date
- February 7, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K200511 | ROSA ONE Brain applicationHAW · Traditional | 05/29/2020SE |
| K192173 | ROSA ONE Spine applicationOLO · Traditional | 10/29/2019SE |
| K182848 | ROSA ONE Spine applicationOLO · Traditional | 03/22/2019SE |
| K172444 | ROSA BRAIN (v3.0.0.5)HAW · Traditional | 03/28/2018SE |
| K151511 | ROSA SpineOLO · Traditional | 01/04/2016SE |
| K151359 | ROSA BrainHAW · Traditional | 12/18/2015SE |
| K092239 | Rosa Surgical Device, Model Rosa 1.1HAW · Traditional | 11/17/2009SE |
Questions and answers
When was ROSA ONE Brain Application cleared by the FDA?
ROSA ONE Brain Application (K182417) received a 510(k) decision of Substantially Equivalent on February 7, 2019, 155 days after the submission was received.
What is the product code of K182417?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.