# K201979: Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine, LLC
- Decided: Aug 25, 2020 after 40 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: 6 generations back to K953730 (1995). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103068: King Cobra Anterior Cervical Plate, Eminent Spine (2011) Summary page 5.
- K133475: Struxxure Anterior Cervical Plate and Screws, Nexxt Spine, LLC (2013) Summary page 5.

## Most influential descendants
- K231145: Axis Anterior Cervical Plate System (2023), 0 descendants of its own

## Indications for use
The Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Source page: https://510kreport.com/device/K201979
Methodology: https://510kreport.com/methodology