# K964533: Ebi Spinelink System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Apr 9, 1997 after 148 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
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 its predicate without a number.
- (no number) Webb-Morley 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) Dyna-Lok® Spine System: named in the summary without a submission number
- (no number) Isola® Spine System: named in the summary without a submission number
- (no number) VSP® Plating System: named in the summary without a submission number
- (no number) KSF Spinal Fixator: named in the summary without a submission number

## Indications for use
The EBI SpineLink™ System (severe spondylolisthesis indication) is intended for patents: (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.

Source page: https://510kreport.com/device/K964533
Methodology: https://510kreport.com/methodology