# K973923: Ebi Spinelink Anterior Cervical Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi Electro Biology
- Decided: Jan 13, 1998 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) EBI Anterior Cervical Spine System: named in the summary without a submission number
- (no number) Anterior Cervical Plate System: named in the summary without a submission number
- (no number) Synthes® Cervical Spine Locking Plate: named in the summary without a submission number

## Most influential descendants
- K022419: Ebi Spinelink Anterior Cervical Spinal System (2002), 0 descendants of its own

## Indications for use
The EBI SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K973923
Methodology: https://510kreport.com/methodology