# K190565: Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Eisertech, LLC
- Decided: May 31, 2019 after 87 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 K926453 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113170: Cervical Plate, Eisertech, LLC (2012) Summary page 4.

## Indications for use
The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications: -Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) -Spondylolisthesis -Fracture -Spinal stenosis -Tumors (primary and metastatic) -Failed previous fusions -Pseudoarthrosis -Deformity (i.e. kyphosis, lordosis, and/or scoliosis).

Source page: https://510kreport.com/device/K190565
Methodology: https://510kreport.com/methodology