# K102449: Bright Spine Galileo Spinal Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Bright Spine, Inc.
- Decided: Feb 11, 2011 after 168 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K081730 (2008). 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)
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 1.

## Indications for use
When used as a cervical intervertebral body fusion device, the GalileoTM Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to TI) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous hone graft. These patients should have had six months of non-operative treatment. The GalileoTM Spinal Spacer System is to be used with a supplemental fixation system.

Source page: https://510kreport.com/device/K102449
Methodology: https://510kreport.com/methodology