Cervical Spinal Disc Implant - Vietnam Registration 2403365ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Cervical Spinal Disc Implant in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403365ĐKLH/BYT-HTTB and manufactured by Medtronic Plc. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Theo theo phụ lục, MEDICREA INTERNATIONAL S.A., and 3 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2403365ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403365ĐKLH/BYT-HTTB

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Device Details

Cervical Spinal Disc Implant

VN: Miếng ghép đĩa đệm cột sống cổ

VERTE-STACK Spinal System

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2403365ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-211214-0039

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

Purpose of Use: The Cervical Disc Spacer VERTE-STACK® is intended to be used as a replacement of the vertebral body to support the surgical correction and stabilization of the spine. The device is indicated for use in one and two levels of the thoracic and anterior lumbar spine. Indications for Use: The Cervical Disc Spacer VERTE-STACK® is a vertebral body replacement device intended for use in the thoracic spine (T1-L5) to replace a deformed, damaged, or unstable vertebral body due to a tumor or trauma (e.g., fracture). The Cervical Disc Spacer VERTE-STACK® will be used in conjunction with additional stabilization. Specifically, the VERTE-STACK® device will be used with the ZPLATE II™ System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE™ System, the TSRH® Spinal System, the CD HORIZON® Spinal System and/or the GDLH® Spinal System from Medtronic. Additionally, the VERTE-STACK® device is intended to be used in conjunction with bone graft.