# K955730: Ebi Anterior Cervical Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Mar 13, 1996 after 86 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 its predicate without a number.
- (no number) Cervical Spine Locking Plate distributed by Synthes: named in the summary without a submission number
- (no number) Songer Titanium Cable System distributed by Sofamor Danek: named in the summary without a submission number
- (no number) Buechel-Pappas™ Total Hip Replacement System distributed by Endotec, Inc.: named in the summary without a submission number

## Indications for use
The EBI® Anterior Cervical Spine System is a single use device, intended for anterior cervical spine applications only Specific indications include the fusion, reduction, alignment or stabilization of the cervical segments of the spine in cases of degenerative disc disease (spondylosis of the cervical spine, cervical spondylotic myelopathy and cervical spondvlosis neuropathy), trauma, and tumors.

Source page: https://510kreport.com/device/K955730
Methodology: https://510kreport.com/methodology