# Pantheon Spinal

- Location (FDA's records): Austin, TX
- FDA decisions: 4 (2013–2024): 4 510(k) clearances
- Product codes: MAX (3), NKB (1)
- 510(k) review time since 2016: median 279 days, against 109 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 4 (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
- Summit Spine: 1 (https://510kreport.com/company/summit-spine)
- Spine360: 1 (https://510kreport.com/company/spine360)
- Titan Spine, LLC: 1 (https://510kreport.com/company/titan-spine)

## Firms that cite its devices most
- Sync Surgical: 1 (https://510kreport.com/company/sync-surgical)

## Its most-cited devices
- K113781: Pantheon Spinal Ibfd System (2013), cited by 2
- K181548: Pantheon Spinal Pontus Interbody Fusion Device (2019), cited by 1
- K241494: Pantheon Pedicle Screw and Iliac Bolt Fixation System (2024), cited by 1

## Recent decisions
- K241494: Pantheon Pedicle Screw and Iliac Bolt Fixation System (Jul 26, 2024)
- K203003: Pantheon IBFD (Jul 7, 2021)
- K181548: Pantheon Spinal Pontus Interbody Fusion Device (Dec 16, 2019)
- K113781: Pantheon Spinal Ibfd System (Apr 26, 2013)

Source page: https://510kreport.com/company/pantheon-spinal