# Ingenium Spine

- Location (FDA's records): Tempe, AZ
- FDA decisions: 2 (2017–2024): 2 510(k) clearances
- Product codes: NKB (2)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 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
- Showa Ika Kohgyo Co., Ltd.: 1 (https://510kreport.com/company/showa-ika-kohgyo)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Its most-cited devices
- K173126: Arisstos™ Spinal System (2017), cited by 1

## Recent decisions
- K241258: Ingenix Spinal System (Jun 4, 2024)
- K173126: Arisstos™ Spinal System (Dec 5, 2017)

Source page: https://510kreport.com/company/ingenium-spine