# K201521: Medina Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Partners, LLC
- Decided: Aug 6, 2020 after 59 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 K922087 (1992). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141993: Nakoma Acp, Alliance Partners, LLC (2014) Summary page 5.
- K060025: Slimplicity Anterior Cervical Plate System, Spinal USA (2006) Summary page 5.
- K091936: Blade Anterior Cervical Plate System, Nexxt Medical, Inc. (2010) Summary page 5.

## Indications for use
The Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications: x Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) x Trauma (including fractures) x Tumors x Deformities or curvatures (including kyphosis, lordosis, or scoliosis) x Pseudoarthrosis x Failed previous fusions x Spondylolisthesis x Spinal Stenosis

Source page: https://510kreport.com/device/K201521
Methodology: https://510kreport.com/methodology