# Phygen, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 7 (2011–2012): 7 510(k) clearances
- Product codes: NKB (6), MNI (1)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Allez Spine, LLC: 8 (https://510kreport.com/company/allez-spine)

## Firms that cite its devices most
- Clearview Orthopedic Development, LLC: 3 (https://510kreport.com/company/clearview-orthopedic-development)
- Captiva Spine, Inc.: 1 (https://510kreport.com/company/captiva-spine)

## Its most-cited devices
- K110588: Leucadia Pedicle Screw System (2011), cited by 4
- K113366: Leucadia Autolok Pedicle Screw System (2012), cited by 1
- K103102: Leucadia Pedicle Screw System (2011), cited by 1
- K103748: Laguna Pedicle Screw System (2011), cited by 1

## Recent decisions
- K120355: Leucadia 4.5 MM Pedicle Screw System (Mar 7, 2012)
- K113366: Leucadia Autolok Pedicle Screw System (Jan 17, 2012)
- K112931: Leucadia (TM) Mis Pedicle Screw System (Nov 2, 2011)
- K110679: Del Mar Monoaxial Pedicle Screw System (Aug 2, 2011)
- K110588: Leucadia Pedicle Screw System (May 25, 2011)
- K103748: Laguna Pedicle Screw System (Mar 2, 2011)
- K103102: Leucadia Pedicle Screw System (Feb 8, 2011)

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