ROSA BRAIN (v3.0.0.5)— 510(k) K172444
Substantially EquivalentMedtech S.A
FDA 510(k) clearance K172444 for ROSA BRAIN (v3.0.0.5), Substantially Equivalent on 2018-03-28. 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 K172444
K-number listed on FDA's recall record- Z-1150-2020 — ROSA Brain 3.0 Application-Brain
- Z-1151-2020 — ROSA One 3.1 Brain Application
- Z-0172-2020 — Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.
- Z-0638-2018 — ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172444.
Data sourced from openFDA. This site is unofficial and independent of the FDA.