# K032752: R&B Surgical Smartplate Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: R&B Surgical Solutions, LLC
- Decided: Dec 3, 2003 after 89 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The R&B Surgical Solutions SmartPlateTM Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. WARNING: The R&B Surgical Solutions SmartPlateTM Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K032752
Methodology: https://510kreport.com/methodology