# Orthofundamentals, LLC

- Location (FDA's records): Medford, MA
- FDA decisions: 1 (2022–2022): 1 510(k) clearance
- Product codes: OUR (1)
- Predicates its devices cite: 5 (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
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Keystone Dental, Inc.: 1 (https://510kreport.com/company/keystone-dental)
- SI-BONE, Inc.: 1 (https://510kreport.com/company/si-bone)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Zyga Technology, Inc.: 1 (https://510kreport.com/company/zyga-technology)

## Recent decisions
- K212962: TRELLIS™ SI Joint Fusion System (Apr 11, 2022)

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