Quantum

Primary DI

90810005669057

Brand

Quantum

Company

NVision Biomedical Technologies, Inc.

Model

PCP-425-12F

Device description

4.25mm dia.12mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • 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. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis

Published

2023-02-01

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

false

Single use

true