PYXIS 3D Titanium Cervical Cage System

Primary DI

08800104077708

Brand

PYXIS 3D Titanium Cervical Cage System

Company

GS Medical Co., Ltd.

Model

8070-0010S

Catalog number

8070-0010S

Device description

The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc.The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient’s pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.

Published

2025-03-17

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

Single use

true