# K971970: Ebi Spinelink System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Aug 20, 1997 after 83 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K964797 (1997). 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)
- K964797: Ebi Spinelink System, Electro-Biology, Inc. (1997) Summary page 1.
- (no number) Webb-Morley Spine System: named in the summary without a submission number
- (no number) Epla Spine System: named in the summary without a submission number
- (no number) TSRH Spinal System: named in the summary without a submission number
- (no number) KSF Spinal Fixator: named in the summary without a submission number
- (no number) Dyna-Lok® Spine System: named in the summary without a submission number
- (no number) VSP® Plating System: named in the summary without a submission number

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

## Indications for use
The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine. 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. 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.

Source page: https://510kreport.com/device/K971970
Methodology: https://510kreport.com/methodology