# K964797: Ebi Spinelink System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: May 2, 1997 after 154 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.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Webb-Morley Spine System - Electro-Biology, Inc.: named in the summary without a submission number
- (no number) Isola® Spine System - AcroMed Corporation: named in the summary without a submission number
- (no number) TSRH® Spinal System - Sofamor Danek: named in the summary without a submission number
- (no number) KSF Spinal Fixator - Tornier SA: named in the summary without a submission number
- (no number) Dyna-Lok® Spine System - Sofamor Danek: named in the summary without a submission number
- (no number) VSP® Plating System - AcroMed Corporation: named in the summary without a submission number

## Most influential descendants
- K971970: Ebi Spinelink System (1997), 1 descendant of its own
- K982908: Modification to Ebi Spinelink System (1998), 0 descendants of its own

## Indications for use
The EBI SpineLink™ System, a spinal fixation device for the noncervical spine, is indicated for (a) anterior fixation, (b) posterior hook and sacral/iliac screw fixation and (c) pedicle screw fixation. When used as an anterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts. When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3-S1 or iliac screw fixation with the fusion only at L5-S1.

Source page: https://510kreport.com/device/K964797
Methodology: https://510kreport.com/methodology