# Keos

- Location (FDA's records): Lancaster, PA
- FDA decisions: 4 (2016–2022): 4 510(k) clearances
- Product codes: MAX (3), ODP (1)
- 510(k) review time since 2016: median 130 days, against 120 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 2 (2 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
- Custom Spine, Inc.: 1 (https://510kreport.com/company/custom-spine)
- Cutting Edge Spine, LLC: 1 (https://510kreport.com/company/cutting-edge-spine)
- Bespoke Technologies, LLC: 1 (https://510kreport.com/company/bespoke-technologies)
- Meditech Spine, LLC: 1 (https://510kreport.com/company/meditech-spine)

## Its most-cited devices
- K160631: Keos Lumbar IBFD (2016), cited by 1
- K163386: Keos Lumbar IBFD (2017), cited by 1

## Recent decisions
- K212450: Keos Anterior Cervical Interbody Fusion Device System (Jun 6, 2022)
- K193174: Keos Lumbar IBFD (Dec 16, 2019)
- K163386: Keos Lumbar IBFD (Apr 10, 2017)
- K160631: Keos Lumbar IBFD (Jul 15, 2016)

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