# Orthofix Medical, Inc.

- Location (FDA's records): Lewisville, TX
- FDA decisions: 1 (2024–2024): 1 510(k) clearance
- Product codes: MAX (1)
- Predicates its devices cite: 12 (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
- SeaSpine Orthopedics Corporation: 7 (https://510kreport.com/company/seaspine-orthopedics)
- Nu Vasive, Incorporated: 3 (https://510kreport.com/company/nu-vasive)
- Wenzel Spine, Inc.: 1 (https://510kreport.com/company/wenzel-spine)
- Orthofix US, LLC: 1 (https://510kreport.com/company/orthofix-us)

## Firms that cite its devices most
- Expanding Innovations, Inc.: 1 (https://510kreport.com/company/expanding-innovations)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)

## Its most-cited devices
- K240830: Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System (2024), cited by 2

## Recent decisions
- K240830: Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System (Jun 20, 2024)

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