# SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A.

**Predicate Speed & CAPA Advisory Opportunity Score:** 30/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261861 |
| Device | SPINEsim v1.0 |
| Applicant | Mdsim S.A. |
| Specialty / panel | Radiology |
| Product code | LLZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-04 |
| Decision date | 2026-09-15 |
| Review time (days) | 103 |
| Third-party review | No |
| Applicant location | Esch-Sur-Alzette, LU |

## Why this score
- Fast 103-day review: this device is a strong predicate for similar products.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261861). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.