# K080815: Tosca II Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Signus Medizintechnik GmbH
- Decided: Apr 23, 2008 after 30 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TOSCA Anterior Cervical Plate System: named in the summary without a submission number

## Most influential descendants
- K132310: ASCOT (2013), 0 descendants of its own

## Indications for use
The TOSCA II Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion. WARNING: The TOSCA II Anterior 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/K080815
Methodology: https://510kreport.com/methodology