# K200883: CarboClear® Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Jun 4, 2020 after 63 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: 2 generations back to K030866 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170224: Spider Cervical Plating System, X-Spine Systems, Inc. (2017) Summary page 5.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 5.
- K040261: Reflex Hybrid Anterior Cervical Plate System, Stryker Spine (2004) Summary page 5.

## Indications for use
CarboClear Cervical Plate System is intended for anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following: Degenerative disc disease (DDD) (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis and tumors, deformity (e.g., scoliosis, kyphosis, lordosis), pseudoarthrosis, failed previous fusions.

Source page: https://510kreport.com/device/K200883
Methodology: https://510kreport.com/methodology