# Sofamor Danek

- Location (FDA's records): Memphis, TN
- FDA decisions: 2 (1999–1999): 1 510(k) clearance and 1 original PMA approval
- Product codes: MNH (1), MAX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 21 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Medtronic Sofamor Danek USA, Inc.: 7 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Titan Spine, LLC: 2 (https://510kreport.com/company/titan-spine)
- Surgicraft, Ltd.: 1 (https://510kreport.com/company/surgicraft)
- Signus Medical, LLC: 1 (https://510kreport.com/company/signus-medical)
- Medicrea Technologies: 1 (https://510kreport.com/company/medicrea-technologies)
- Difusion Technologies: 1 (https://510kreport.com/company/difusion-technologies)
- Spine Smith Partners L.P.: 1 (https://510kreport.com/company/spine-smith-partners)

## Its most-cited devices
- P970015: Inter Fix Threaded Fusion Device (1999), cited by 19
- K991460: Modification to Zplate-Atl Anterior Fixation System (1999), cited by 2

## Recent decisions
- K991460: Modification to Zplate-Atl Anterior Fixation System (May 19, 1999)
- P970015: Inter Fix Threaded Fusion Device (May 14, 1999)

Source page: https://510kreport.com/company/sofamor-danek