# K060379: Ebi Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Mar 6, 2006 after 20 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.
207 later devices descend from it; 4 cite it directly.
0 of 208 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 VueLock Anterior Cervical Plate System: named in the summary without a submission number
- (no number) EBI SpineLink Anterior Cervical Plate System: named in the summary without a submission number
- (no number) Interpore Cross International C-Tek Anterior Cervical Plate System: named in the summary without a submission number
- (no number) Synthes Spine Anterior Cervical Vertebrae Plate System (Anterior CSLP): named in the summary without a submission number

## Most influential descendants
- K080646: C-Tek Maxan Anterior Cervical Plate System (2008), 193 descendants of its own
- K133475: Struxxure Anterior Cervical Plate and Screws (2013), 132 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own

## Indications for use
The EBI Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. 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 confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthroses and/or failed previous fusions.

Source page: https://510kreport.com/device/K060379
Methodology: https://510kreport.com/methodology