# Axis Orthopaedics

- Location (FDA's records): Soldotna, AK
- FDA decisions: 3 (2018–2018): 3 510(k) clearances
- Product codes: KWQ (1), ODP (1), NKB (1)
- 510(k) review time since 2016: median 106 days, against 95 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 3 (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
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Choicespine, LP: 1 (https://510kreport.com/company/choicespine)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)

## Firms that cite its devices most
- Kahtnu Surgical, Inc.: 2 (https://510kreport.com/company/kahtnu-surgical)
- Legend Spine Technologies: 1 (https://510kreport.com/company/legend-spine-technologies)

## Its most-cited devices
- K181140: Axis Chena Cervical PEEK Spacer System (2018), cited by 2
- K173867: Axis Anterior Cervical Plate System (2018), cited by 1

## Recent decisions
- K181140: Axis Chena Cervical PEEK Spacer System (Nov 16, 2018)
- K180301: AXIS 5.5 Lumbar Pedicle Screw System (Apr 10, 2018)
- K173867: Axis Anterior Cervical Plate System (Apr 5, 2018)

Source page: https://510kreport.com/company/axis-orthopaedics