# Spinal Alignment Solutions, Inc.

- Location (FDA's records): Tiverton, RI
- FDA decisions: 2 (2024–2026): 2 510(k) clearances
- Product codes: NKB (2)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 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 USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)

## Its most-cited devices
- K242350: Spinal Alignment Solutions Pelvic Incidence (PI) Rod System (2024), cited by 1

## Recent decisions
- K263172: SAS MIS Pelvic Incidence Rods (Sep 30, 2026)
- K242350: Spinal Alignment Solutions Pelvic Incidence (PI) Rod System (Oct 28, 2024)

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