# Dfine, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 5 (2006–2010): 5 510(k) clearances
- Product codes: NDN (4), GEI (1)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 5 (3 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
- Arthrocare Corp.: 3 (https://510kreport.com/company/arthrocare)
- Tecres S.P.A.: 1 (https://510kreport.com/company/tecres)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Disc-O-Tech Medical Technologies, Ltd.: 1 (https://510kreport.com/company/disc-o-tech-medical-technologies)

## Firms that cite its devices most
- Baylis Medical Co., Inc.: 2 (https://510kreport.com/company/baylis-medical)

## Its most-cited devices
- K091310: Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 (2010), cited by 2
- K072496: Modification to Space Cpsxl Bone Cement (2007), cited by 1
- K061531: Space Cpsxl Bone Cement (2006), cited by 1
- K070351: Space 360 Delivery System (2007), cited by 1

## Recent decisions
- K091310: Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 (Aug 11, 2010)
- K090986: Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/ Stabilit Erx Bone Cement) (Dec 30, 2009)
- K072496: Modification to Space Cpsxl Bone Cement (Oct 5, 2007)
- K070351: Space 360 Delivery System (Jun 29, 2007)
- K061531: Space Cpsxl Bone Cement (Aug 30, 2006)

Source page: https://510kreport.com/company/dfine