# K071990: Valeo Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Corp.
- Decided: Oct 29, 2007 after 101 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: 4 generations back to K922087 (1992). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982443: Doc Ventral Cervical Stabilization System, Depuy Motech Acromed (1998) Summary page 2.
- K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 2.
- K973854: Orion Anterior Cervical Plate System, Sofamor Danek USA,Inc. (1998) Summary page 2.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 2.
- K010466: Tether Acfs, Theken Surgical,Llc (2001) Summary page 2.
- K010003: Ebi Vuelock Anterior Cervical Plate System, Ebi, L.P. (2001) Summary page 2.
- K053581: Nuvasive Smartplate Gradient Plus System, Nuvasive, Inc. (2006) Summary page 2.
- K992920: Ebi Spinelink System, Ebi, L.P. (1999) Summary page 2.
- K040017: Abc Caudal and Cranial Extension Plate (E-Plate), Aesculap, Inc. (2004) Summary page 2.

## Most influential descendants
- K082037: Seeplate Cervical Plate System (2008), 0 descendants of its own

## Indications for use
The ValeoTM Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The ValeoTM Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Source page: https://510kreport.com/device/K071990
Methodology: https://510kreport.com/methodology