# Spineworks, LLC

- Location (FDA's records): Round Rock, TX
- FDA decisions: 4 (2005–2014): 4 510(k) clearances
- Product codes: MAX (2), MQP (1), MNH (1)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 6 (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
- Spinal Elements, Inc.: 2 (https://510kreport.com/company/spinal-elements)
- Nuvasive, Inc.: 2 (https://510kreport.com/company/nuvasive)
- Seaspine, Inc.: 1 (https://510kreport.com/company/seaspine)
- Acme Spine, LLC: 1 (https://510kreport.com/company/acme-spine)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)
- Sapphire Medical Group: 1 (https://510kreport.com/company/sapphire-medical-group)
- Difusion Technologies: 1 (https://510kreport.com/company/difusion-technologies)

## Firms that cite its devices most
- Pioneer Surgical Technology: 1 (https://510kreport.com/company/pioneer-surgical-technology)
- Genesys Spine: 1 (https://510kreport.com/company/genesys-spine)
- Spinal Stability, LLC: 1 (https://510kreport.com/company/spinal-stability)
- Innovasis, Inc.: 1 (https://510kreport.com/company/innovasis)
- Sapphire Medical Group: 1 (https://510kreport.com/company/sapphire-medical-group)

## Its most-cited devices
- K111166: A-Wedge Anterior Interbody System (a-Wedge a.I.S.) (2011), cited by 3
- K081331: Fixxsure Cross Link (2008), cited by 2
- K133340: Spineworks Anterior Lumbar Device (2014), cited by 1

## Recent decisions
- K133340: Spineworks Anterior Lumbar Device (Apr 11, 2014)
- K111166: A-Wedge Anterior Interbody System (a-Wedge a.I.S.) (Sep 8, 2011)
- K081331: Fixxsure Cross Link (Jul 23, 2008)
- K042600: Stansion Matrix (Feb 18, 2005)

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