# Spineway

- Location (FDA's records): Ecully, FR
- FDA decisions: 7 (2015–2023): 7 510(k) clearances
- Names in FDA's records: Spineway (5); Spineway SA (2)
- Product codes: NKB (4), MAX (1), KWQ (1), ODP (1)
- 510(k) review time since 2016: median 92 days, against 84 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 18 (3 its own); citations of its devices by later devices: 6 (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
- Qualgenix: 3 (https://510kreport.com/company/qualgenix)
- Depuy Spine, A Johnson & Johnson Company: 2 (https://510kreport.com/company/depuy-spine-a-johnson-johnson)
- Stryker Spine: 2 (https://510kreport.com/company/stryker-spine)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)
- Spineart: 1 (https://510kreport.com/company/spineart)
- Scient'X USA, Inc.: 1 (https://510kreport.com/company/scient-x-usa)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Orbbo Surgical, LLC: 2 (https://510kreport.com/company/orbbo-surgical)
- Socko Medical Co., Ltd.: 1 (https://510kreport.com/company/socko-medical)

## Its most-cited devices
- K161387: Mont Blanc and Mont Blanc MIS Spinal Systems (2016), cited by 3
- K152355: Twin Peaks Lumbar Interbody Fusion System (2015), cited by 1
- K150185: Mont Blanc Spinal System (2015), cited by 1
- K150036: Blue Mountain Cervical Plate System (2015), cited by 1

## Recent decisions
- K231658: VEOS Spinal Fixation System (Oct 10, 2023)
- K191726: mont blanc & mont blanc MIS Spinal Systems (Sep 12, 2019)
- K162694: Ayers Rock Cervical interbody fusion system (Jan 12, 2017)
- K161387: Mont Blanc and Mont Blanc MIS Spinal Systems (Aug 4, 2016)
- K152355: Twin Peaks Lumbar Interbody Fusion System (Dec 10, 2015)
- K150185: Mont Blanc Spinal System (May 12, 2015)
- K150036: Blue Mountain Cervical Plate System (May 7, 2015)

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