# Ortosim, S.A. DE C.V.

- Location (FDA's records): Littleton, CO
- FDA decisions: 1 (2003–2003): 1 510(k) clearance
- Product codes: DZB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K032392: Morales Protraction Facemask (Oct 22, 2003)

Source page: https://510kreport.com/company/ortosim