# Fusion Innovations, LLC

- Location (FDA's records): Maitland, FL
- FDA decisions: 2 (2022–2025): 2 510(k) clearances
- Product codes: HRS (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Biomet Microfixation: 2 (https://510kreport.com/company/biomet-microfixation)

## Its most-cited devices
- K202914: SternaFuse Fixation System (2022), cited by 1

## Recent decisions
- K252661: SternaFuse Ti Fixation System (Nov 19, 2025)
- K202914: SternaFuse Fixation System (Jan 26, 2022)

Source page: https://510kreport.com/company/fusion-innovations