# Intrauma S.P.A

- Location (FDA's records): Rivoli (To), IT
- FDA decisions: 3 (2021–2025): 3 510(k) clearances
- Product codes: HRS (2), HSB (1)
- 510(k) review time since 2016: median 179 days, against 94 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 7 (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

## Firms whose devices it cites most
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- Howmedica Osteonics Corp.: 2 (https://510kreport.com/company/howmedica-osteonics)
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)

## Recent decisions
- K252959: WRISTAR MultiAx Distal Radius Kit (Nov 12, 2025)
- K230623: KITE Distal Fibula Kit (Sep 1, 2023)
- K201147: Elos® Intramedullary Nailing System (Jul 19, 2021)

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