# Qualgenix

- Location (FDA's records): Oxford, CT
- FDA decisions: 4 (2012–2012): 4 510(k) clearances
- Names in FDA's records: Qualgenix (2); Qualgenix, LLC (2)
- Product codes: NKB (1), MAX (1), KWQ (1), ODP (1)
- Predicates its devices cite: 21 (0 its own); citations of its devices by later devices: 4 (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 whose devices it cites most
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Spineart: 2 (https://510kreport.com/company/spineart)
- Scient'X USA, Inc.: 2 (https://510kreport.com/company/scient-x-usa)
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)
- Cross Medical Products, Inc.: 1 (https://510kreport.com/company/cross-medical-products)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Sulzer Spine-Tech: 1 (https://510kreport.com/company/sulzer-spine-tech)

## Firms that cite its devices most
- Spineway: 3 (https://510kreport.com/company/spineway)
- Orbbo Surgical, LLC: 1 (https://510kreport.com/company/orbbo-surgical)

## Its most-cited devices
- K112801: Ayers Rock Cervical Cage (2012), cited by 2
- K112684: Mont Blanc Pedicle Screw Systems (2012), cited by 1
- K112809: Blue Mountain Cervical Plate (2012), cited by 1

## Recent decisions
- K112809: Blue Mountain Cervical Plate (Jun 20, 2012)
- K112684: Mont Blanc Pedicle Screw Systems (May 1, 2012)
- K112801: Ayers Rock Cervical Cage (May 1, 2012)
- K112696: Twin Peaks Lumbar Cage (Apr 18, 2012)

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