# Novalign Orthopaedics, Inc.

- Location (FDA's records): Memphis, TN
- FDA decisions: 1 (2009–2009): 1 510(k) clearance
- Product codes: HSB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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 that cite its devices most
- Satori Orthopaedics, Inc.: 1 (https://510kreport.com/company/satori-orthopaedics)

## Its most-cited devices
- K083458: Intramedullary Fixation Rod (Ifs) (2009), cited by 1

## Recent decisions
- K083458: Intramedullary Fixation Rod (Ifs) (Feb 9, 2009)

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