# K113170: Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Eisertech, LLC
- Decided: Apr 6, 2012 after 162 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: 1 generation back to K926453 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974885: Blackstone Medical Inc. Anterior Cervical Plate System, Blackstone Medical, Inc. (1998) Summary page 1.
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 1.

## Most influential descendants
- K190565: Cervical Plate (2019), 0 descendants of its own

## 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/K113170
Methodology: https://510kreport.com/methodology