# K963780: Dual Rod Anterior Fixator System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Jul 30, 1997 after 313 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- 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 Dual Rod Anterior Fixator System is designed to aid in the surgical correction and stabilization of the spine. The system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the Dual Rod Anterior Fixator System are the following: Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Pseudoarthrosis Stenosis Spondylolisthesis Spinal deformities: scoliosis, kyphosis, lordosis Fracture Unsuccessful previous attempts at spinal fusion Tumor resection All components of the Dual Rod Anterior Fixator System are intended to be fixed/attached to the anterolateral spine by bolts/connector spikes in the thoracic and/or lumbar areas only.

Source page: https://510kreport.com/device/K963780
Methodology: https://510kreport.com/methodology