# K223753: Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Mar 14, 2023 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
Longest line of descent: 8 generations back to K953730 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141632: Zevo (TM) Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Indications for use
Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1 and is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1)degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2)trauma (including fractures); 3)tumors; 4)deformity(defined as kyphosis, lordosis,or scoliosis); 5)pseudoarthrosis; 6)failed previous fusions

Source page: https://510kreport.com/device/K223753
Methodology: https://510kreport.com/methodology