# Medtronic Sofamor Danek USA, Inc.

- Location (FDA's records): Memphis, TN
- FDA decisions: 188 (2000–2026): 184 510(k) clearances and 4 original PMA approvals
- Names in FDA's records: Medtronic Sofamor Danek USA, Inc. (177); Medtronic Sofamor Danek USA (9); Medtronic Sofamor Danek USA, Incorporated (2)
- Product codes: NKB (48), MAX (38), OLO (15), KWP (10), KWQ (9), ODP (8), NKG (7), MQP (6), MQV (5), OVD (3), GEI (3), KCT (3)
- 510(k) review time since 2016: median 86 days, against 93 for FDA's reviews in the same codes and years (46 of 73 faster)
- Predicates its devices cite: 715 (314 its own); citations of its devices by later devices: 858 (314 its own)
- Recalls linked to its devices: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek: 272 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic, Inc.: 21 (https://510kreport.com/company/medtronic)
- Sofamor Danek USA,Inc.: 8 (https://510kreport.com/company/sofamor-danek-usa)
- Medtronic Navigation, Inc.: 8 (https://510kreport.com/company/medtronic-navigation)
- Sofamor Danek: 7 (https://510kreport.com/company/sofamor-danek)
- Medtronic Xomed, Inc.: 7 (https://510kreport.com/company/medtronic-xomed)
- Medtronic Sofamor Danck USA, Inc.: 6 (https://510kreport.com/company/medtronic-sofamor-danck-usa)
- Depuy Spine, Inc.: 5 (https://510kreport.com/company/depuy-spine)

## Firms that cite its devices most
- Medtronic Sofamor Danek: 108 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic, Inc.: 29 (https://510kreport.com/company/medtronic)
- K2m, Inc.: 17 (https://510kreport.com/company/k2m)
- Globus Medical, Inc.: 16 (https://510kreport.com/company/globus-medical)
- Spineart: 16 (https://510kreport.com/company/spineart)
- Medicrea International SA: 12 (https://510kreport.com/company/medicrea-international)
- Astura Medical: 10 (https://510kreport.com/company/astura-medical)
- Nu Vasive, Incorporated: 10 (https://510kreport.com/company/nu-vasive)

## Its most-cited devices
- K140454: Navigated CD Horizon Solera Screwdriver/Taps (2014), cited by 49
- K073291: Capstone Spinal System (2008), cited by 41
- K113174: CD Horizon Spinal System (2011), cited by 37
- K031655: CD Horizon Spinal System (2003), cited by 25
- K143628: Navigated Vertex Select Instruments (2015), cited by 20
- K120368: Capstone Control Spinal System (2012), cited by 19

## Recent decisions
- K253011: Catalyft PL Expandable Interbody System (Jul 17, 2026)
- K261020: Symmetrix™ L Spinal System (Jul 14, 2026)
- K253656: OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (Jun 5, 2026)
- K260216: CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System (Apr 21, 2026)
- K254165: Infinity™ OCT System (Jan 21, 2026)
- K253941: CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (Jan 7, 2026)
- K253335: CD Horizon™ Spinal System (Oct 24, 2025)
- K253129: Infinity™ OCT System (Oct 24, 2025)

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