# K022419: Ebi Spinelink Anterior Cervical Spinal System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Aug 12, 2002 after 19 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
Longest line of descent: 1 generation back to K973923 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973923: Ebi Spinelink Anterior Cervical Spinal System, Ebi Electro Biology (1998) Summary page 1.
- K991092: Ebi Spinelink Anterior Cervical Spinal System, Electro-Biology, Inc. (1999) Summary page 1.
- K993822: Ebi Spinelink Anterior Cervical Spinal System, Ebi, L.P. (1999) Summary page 1.
- K000513: Modification to Ebi Spinelink Anterior Cervical Spinal System, Ebi, L.P. (2000)

## Indications for use
The EBI@SpineLinkTMAnterior 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 fiactures), 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/K022419
Methodology: https://510kreport.com/methodology