Vietnam MOH registration 2403365ĐKLH/BYT-HTTB

Cervical Spinal Disc Implant

VN: Miếng ghép đĩa đệm cột sống cổ
VERTE-STACK Spinal System
Vietnam flagVietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Medtronic Plc·Registered Nov 06, 2024
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
Company information
Manufacturer
Medtronic Plc
Manufacturer Country
Theo theo phụ lục
Product Owner
Medtronic Plc
Authorized Representative
CÔNG TY TNHH MEDTRONIC VIỆT NAM
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.
Dates and status
Registration Date
Nov 06, 2024
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About this record

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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