# K162250: FortiBridge Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Nanovis Spine, LLC
- Decided: Oct 26, 2016 after 77 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: 8 generations back to K953730 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143706: FortiBridge Anterior Cervical Plate System, Nanovis Spine, LLC (2015) Summary page 5.
- K133518: Maxan Anterior Cervical Plate System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 5.

## Indications for use
The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

Source page: https://510kreport.com/device/K162250
Methodology: https://510kreport.com/methodology