# Infix Medical, LLC

- Location (FDA's records): Gulf Breeze, FL
- FDA decisions: 1 (2015–2015): 1 510(k) clearance
- Product codes: HWC (1)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 1 (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): 6 (https://510kreport.com/company/synthes-usa)
- Ortho Solutions Limited: 1 (https://510kreport.com/company/ortho-solutions)

## Firms that cite its devices most
- Neoortho Produtos Ortopedicos S/A: 1 (https://510kreport.com/company/neoortho-produtos-ortopedicos-s-a)

## Its most-cited devices
- K142057: Infix Cannulated Screw System (2015), cited by 1

## Recent decisions
- K142057: Infix Cannulated Screw System (Jan 13, 2015)

Source page: https://510kreport.com/company/infix-medical