# Co-Ligne AG

- Location (FDA's records): Concord, CA
- FDA decisions: 4 (2004–2009): 4 510(k) clearances
- Product codes: MNH (3), MQP (1)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 7 (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
- Karen E. Warden, M.E.B.E.: 3 (https://510kreport.com/company/karen-e-warden-mebe)
- Acromed Corp.: 1 (https://510kreport.com/company/acromed)
- Depuyacromed: 1 (https://510kreport.com/company/depuyacromed)
- Lanx, Inc.: 1 (https://510kreport.com/company/lanx)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)
- Theken Surgical,Llc: 1 (https://510kreport.com/company/theken-surgical)

## Firms that cite its devices most
- Coligne AG: 3 (https://510kreport.com/company/coligne)
- Back 2 Basics Direct, LLC: 1 (https://510kreport.com/company/back-2-basics-direct)

## Its most-cited devices
- K032604: Gii Spinal Fixation System (2004), cited by 3
- K051089: Gii Spinal Fixation System (2005), cited by 2
- K083567: Gii Spinal Fixation System, Gii-TI-Poly Axial Screw (2009), cited by 1
- K072326: Ostapek VBR System (2008), cited by 1

## Recent decisions
- K083567: Gii Spinal Fixation System, Gii-TI-Poly Axial Screw (Sep 14, 2009)
- K072326: Ostapek VBR System (Jun 24, 2008)
- K051089: Gii Spinal Fixation System (Oct 26, 2005)
- K032604: Gii Spinal Fixation System (Jan 20, 2004)

Source page: https://510kreport.com/company/co-ligne