ORTHOPAEDIC PROSTHESES FIXING ELEMENTS - NOT OTHERWISE CLASSIFIED

Primary DI

06939488503250

Basic UDI-DI Code

B-06939488503250

Reference

GT-0325

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Dragon Crown Medical Co.,Ltd.

A sterile implantable device designed as a small pouch for percutaneous insertion into a vertebral body and inflated through the injection of orthopaedic cement, intended to provide a bone filler container ( BFC) that ensures leakage- free containment of the cement within the vertebral body to restore its height during vertebroplasty and kyphoplasty. It is typically made of a non- bioabsorbable, non-stretchable fabric; implantation instruments may be included. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat patients diagnosed with vertebral compression fractures ( VCFs) in the lumbar or thoracic region of the spine.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).