# Coligne AG

- Location (FDA's records): Zurich, CH
- FDA decisions: 4 (2017–2021): 4 510(k) clearances
- Product codes: ODP (1), MAX (1), PLR (1), NKB (1)
- 510(k) review time since 2016: median 110 days, against 109 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 14 (0 its own); citations of its devices by later devices: 2 (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
- Co-Ligne AG: 3 (https://510kreport.com/company/co-ligne)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- L&K BIOMED Co., Ltd.: 2 (https://510kreport.com/company/l-k-biomed)
- Spinal Elements, Inc.: 1 (https://510kreport.com/company/spinal-elements)
- Sulzer Spine-Tech: 1 (https://510kreport.com/company/sulzer-spine-tech)
- Ldr Spine USA: 1 (https://510kreport.com/company/ldr-spine-usa)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Zimmer Spine, Inc.: 1 (https://510kreport.com/company/zimmer-spine)

## Firms that cite its devices most
- Acro Composites, LLC: 2 (https://510kreport.com/company/acro-composites)

## Its most-cited devices
- K173148: ACIF (2017), cited by 1
- K181963: ostaPek Interbody Fusion Cages (2018), cited by 1

## Recent decisions
- K210306: GII Spinal Fixation System (May 19, 2021)
- K181963: ostaPek Interbody Fusion Cages (Nov 14, 2018)
- K173893: Trabis (Sep 6, 2018)
- K173148: ACIF (Dec 1, 2017)

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