# Allez Spine, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 7 (2005–2009): 7 510(k) clearances
- Product codes: NKB (5), MNH (1), MNI (1)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 10 (2 its own)
- Recalls linked to its devices: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sofamor Danek USA,Inc.: 1 (https://510kreport.com/company/sofamor-danek-usa)
- Blackstone Medical, Inc.: 1 (https://510kreport.com/company/blackstone-medical)

## Firms that cite its devices most
- Phygen, LLC: 8 (https://510kreport.com/company/phygen)

## Its most-cited devices
- K050060: Laguna Pedicle Screw System (2005), cited by 4
- K083826: Laguna Polyaxial Pedicle Screw System (2009), cited by 2
- K051275: Laguna Monoaxial Pedicle Screw System (2005), cited by 1
- K091219: Del Mar Monoaxial Pedicle Screw System (2009), cited by 1
- K091995: Laguna Size 8 Pedicle Screw System (2009), cited by 1
- K072678: Laguna Size 8 Pedicle Screw (2008), cited by 1

## Recent decisions
- K091995: Laguna Size 8 Pedicle Screw System (Aug 7, 2009)
- K091219: Del Mar Monoaxial Pedicle Screw System (Jul 9, 2009)
- K083826: Laguna Polyaxial Pedicle Screw System (Jan 22, 2009)
- K072678: Laguna Size 8 Pedicle Screw (Jul 2, 2008)
- K070460: Allez Spine Cross Connectors (Jun 11, 2007)
- K051275: Laguna Monoaxial Pedicle Screw System (Dec 9, 2005)
- K050060: Laguna Pedicle Screw System (May 4, 2005)

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