# K032102: Vertelink Kobra Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Vertelink Corporation
- Decided: Dec 12, 2003 after 157 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
Longest line of descent: 1 generation back to K030932 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030932: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2003) Summary page 1.

## Most influential descendants
- K042859: Kobra GPS Fixation System (2004), 0 descendants of its own

## Indications for use
1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spinal stenosis, 3) Spondylolisthesis, 4) Spinal deformities, 5) Fractures, 6) Pseudarthrosis, 7) Tumor resection, 8) Failed previous Fusion. When used as Fixation system the multiaxial screw components are also indicated for skeletally mature patients: a. Having severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebral joint, b. Who are receiving fusion using authogeneous bone graft only, c. Who are having the device fixed or attached to the lumbar or sacral spine (L3 and below), d. Who are having the device removed after the development of solid fusion mass.

Source page: https://510kreport.com/device/K032102
Methodology: https://510kreport.com/methodology