# Medtronic Sofamor Danck USA, Inc.

- Location (FDA's records): Memphis, TN
- FDA decisions: 4 (2011–2015): 4 510(k) clearances
- Product codes: NKB (2), NDN (1), ODP (1)
- Predicates its devices cite: 9 (0 its own); citations of its devices by later devices: 14 (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: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic, Inc.: 2 (https://510kreport.com/company/medtronic)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)
- Life Spine, Inc.: 1 (https://510kreport.com/company/life-spine)

## Firms that cite its devices most
- Medtronic Sofamor Danek USA, Inc.: 6 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- K2m, Inc.: 2 (https://510kreport.com/company/k2m)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Biomet Spine (Aka Ebi, LLC): 1 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Precifit Medical, Ltd.: 1 (https://510kreport.com/company/precifit-medical)

## Its most-cited devices
- K112444: Anatomic Peek Cervical Fusion System (2011), cited by 5
- K110070: TSRH Spinal System (2011), cited by 5
- K150460: KYPHON (R) HV-R (R) Bone Cement (2015), cited by 2
- K142847: CD HORIZON Spinal System (2014), cited by 2

## Recent decisions
- K150460: KYPHON (R) HV-R (R) Bone Cement (Apr 28, 2015)
- K142847: CD HORIZON Spinal System (Oct 27, 2014)
- K112444: Anatomic Peek Cervical Fusion System (Nov 15, 2011)
- K110070: TSRH Spinal System (Jun 8, 2011)

Source page: https://510kreport.com/company/medtronic-sofamor-danck-usa