ROSA ONE Brain Application— 510(k) K182417
Substantially EquivalentMedtech S.A
FDA 510(k) clearance K182417 for ROSA ONE Brain Application, Substantially Equivalent on 2019-02-07. Applicant: Medtech S.A. Device class: 2.
Clearance details
- Applicant
- Medtech S.A
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montpellier, FR
Recent devices under product code HAW
view allMore clearances from Medtech S.A
view allAdverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K182417
K-number listed on FDA's recall record- Z-0118-2022 — ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
- Z-1150-2020 — ROSA Brain 3.0 Application-Brain
- Z-1151-2020 — ROSA One 3.1 Brain Application
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182417.
Data sourced from openFDA. This site is unofficial and independent of the FDA.