# Medtronic Soafamor Danek

- Location (FDA's records): Memphis, TN
- FDA decisions: 1 (2009–2009): 1 510(k) clearance
- Product codes: KWP (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 6 (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
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Firms that cite its devices most
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)
- Biomet Spine (Aka Ebi, LLC): 1 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Spinecraft, LLC: 1 (https://510kreport.com/company/spinecraft)

## Its most-cited devices
- K091365: Vertex Reconstruction System, Vertex Select Reconstruction System (2009), cited by 6

## Recent decisions
- K091365: Vertex Reconstruction System, Vertex Select Reconstruction System (Aug 6, 2009)

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