# K231134: VerteLoc Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Feb 13, 2024 after 298 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The VerteLoc Spinal System is indicated for use as a cervical vertebral body replacement (VBR) fusion device in the cervical spine (C3-C7) in skeletally mature patients for partial or total replacement of diseased, collapsed, damaged or unstable vertebral body due to tumour, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The VerteLoc Spinal System is to be used with bone graft material. The VerteLoc Spinal System is intended for use with supplemental internal fixation that has been cleared by the FDA.

Source page: https://510kreport.com/device/K231134
Methodology: https://510kreport.com/methodology