# K070460: Allez Spine Cross Connectors

- Pathway: 510(k) (Traditional)
- Applicant: Allez Spine, LLC
- Decided: Jun 11, 2007 after 115 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003735 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003735: Blackstone Spinal Fixation System, Second-Generation Cross-Connector, Blackstone Medical, Inc. (2001) Summary page 1.

## Recalls of this device
- Aug 21, 2008 · Not classified · Z-0155-2009: This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regar

## Indications for use
The LAGUNA SPINAL SYSTEM is intended for posterior, non-cervical pedicle fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.

Source page: https://510kreport.com/device/K070460
Methodology: https://510kreport.com/methodology