# K062686: Universal Spinal Anterior Locking Plate System

- Pathway: 510(k) (Special)
- Applicant: Advanced Spine Technology, Inc.
- Decided: Oct 5, 2006 after 27 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 K905023 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905023: Amset Locking Plate System, Advanced Med/Surg, Inc. (1992) Summary page 1.

## Indications for use
The Universal Spinal Anterior Locking Plate System is intended for anterior/anterolateral fixation for the following indications: * degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * spondylolisthesis; * trauma (i.e., fracture or dislocation); * spinal stenosis; * curvatures (i.e., scoliosis, kyphosis, and/or lordosis); * tumor; * pseudoarthrosis; * and failed previous fusion. This device 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/K062686
Methodology: https://510kreport.com/methodology