# Axon Spine Medical System

- Location (FDA's records): Pompei, IT
- FDA decisions: 1 (2023–2023): 1 510(k) clearance
- Product codes: GEI (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (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 USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)

## Recent decisions
- K223303: Spinery™ RF Ablation System (Aug 30, 2023)

Source page: https://510kreport.com/company/axon-spine-medical-system