# K230993: CODA™ Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
- Decided: Jun 20, 2023 after 75 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: 5 generations back to K953730 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222493: CODA™ Anterior Cervical Plate System, Pioneer Surgical Technology, Inc. (2022) Summary page 4.

## Indications for use
The CODA™ Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K230993
Methodology: https://510kreport.com/methodology