# Surgalign Spine Technologies

- Location (FDA's records): Deerfield, IL
- FDA decisions: 3 (2022–2023): 3 510(k) clearances
- Product codes: SBF (2), NKB (1)
- 510(k) review time since 2016: median 95 days, against 104 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)

## Firms that cite its devices most
- Xtant Medical Holdings, Inc.: 1 (https://510kreport.com/company/xtant-medical-holdings)

## Its most-cited devices
- K221403: Cortera Spinal Fixation System (2022), cited by 1
- K211254: ARAI Surgical Navigation System (2022), cited by 1

## Recent decisions
- K231611: HOLO Portal™ Surgical Guidance System (Aug 31, 2023)
- K221403: Cortera Spinal Fixation System (Aug 19, 2022)
- K211254: ARAI Surgical Navigation System (Jan 14, 2022)

Source page: https://510kreport.com/company/surgalign-spine-technologies