# Intrafuse, LLC

- Location (FDA's records): Logan, UT
- FDA decisions: 2 (2017–2017): 2 510(k) clearances
- Product codes: HSB (2)
- Predicates its devices cite: 14 (0 its own); citations of its devices by later devices: 2 (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): 5 (https://510kreport.com/company/synthes-usa)
- Sonoma Orthopedic Products, Inc.: 3 (https://510kreport.com/company/sonoma-orthopedic-products)
- Acumed, LLC: 3 (https://510kreport.com/company/acumed)
- Mahe Medical GmbH: 1 (https://510kreport.com/company/mahe-medical)
- Sonoma Orthopedics Products, Inc.: 1 (https://510kreport.com/company/sonoma-orthopedics-products)
- Advanced Orthopaedic Solutions, Inc.: 1 (https://510kreport.com/company/advanced-orthopaedic-solutions)

## Firms that cite its devices most
- BAAT Medical Products B.V.: 1 (https://510kreport.com/company/baat-medical-products)
- Conventus Orthopaedics, Inc.: 1 (https://510kreport.com/company/conventus-orthopaedics)

## Its most-cited devices
- K172943: Flex-Thread Fibula Pin System (2017), cited by 1
- K163488: Flex-Thread Clavicle Pin System (2017), cited by 1

## Recent decisions
- K172943: Flex-Thread Fibula Pin System (Oct 30, 2017)
- K163488: Flex-Thread Clavicle Pin System (Mar 20, 2017)

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