# K190170: MVP Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: May 13, 2019 after 101 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: 4 generations back to K971730 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 5.
- K073275: Nuvasive Helix Mini Acp System, Nuvasive, Inc. (2008) Summary page 5.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 5.

## Indications for use
The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: • Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) • Spondylolisthesis • Trauma (including fracture or dislocation) • Spinal Stenosis • Deformities or curvatures (kyphosis, lordosis, or scoliosis) • Tumors • Pseudoarthrosis • Failed Previous Fusion

Source page: https://510kreport.com/device/K190170
Methodology: https://510kreport.com/methodology