# Dne, LLC

- Location (FDA's records): Round Rock, TX
- FDA decisions: 3 (2012–2016): 3 510(k) clearances
- Product codes: KTT (3)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- R&R Medical Corporation, Ltd.: 2 (https://510kreport.com/company/r-r-medical)
- Small Bone Innovations, Inc.: 1 (https://510kreport.com/company/small-bone-innovations)
- Vilex, LLC: 1 (https://510kreport.com/company/vilex)
- Electro-Biology, Inc.: 1 (https://510kreport.com/company/electro-biology)
- Ebi, L.P.: 1 (https://510kreport.com/company/ebi)

## Firms that cite its devices most
- Medusa Orthopedics, LLC: 1 (https://510kreport.com/company/medusa-orthopedics)

## Its most-cited devices
- K113106: Dne External Fixation System (2012), cited by 2

## Recent decisions
- K151580: D.N.E. External Fixation System (Feb 16, 2016)
- K140158: S.E.a.L. Fracture Fusion Tube (May 29, 2014)
- K113106: Dne External Fixation System (Jan 4, 2012)

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