Vietnam MOH registration 2402652ĐKLH/BYT-HTTB

Spinal Column Stabilization Module

VN: Bộ ổn định cột sống

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Globus Medical, Inc·Registered Oct 02, 2024

Registration details

Analysis ID: 2402652ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-201109-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Globus Medical, Inc
Manufacturer Country: Theo theo phụ lục
Product Owner: Globus Medical, Inc
Authorized Representative: CÔNG TY CỔ PHẦN VIỆT - SING MEDICAL

Technical details

Intended Use: - The spinal stabilization system is effective in stabilizing and fixing the vertebrae as a bone fusion treatment option for acute and chronic instability, deformity of the thoracic, lumbar and sacral vertebrae in the adult human spine, and slippage of the vertebrae due to degeneration with clear evidence of neurological deterioration, kyphosis, or failure of prior spinal fusion surgery (arthrodesis). - In addition, the spinal stabilization system is used in: bone fusion with autograft bone grafts, patients with spinal fixation devices or attached to the lumbar spine or both, and patients with spinal fixation devices that were removed after complete bone fusion - The spinal stabilization system is indicated for use when bone fusion with autograft bone grafts is placed at all levels where the device is intended to be placed.

Dates and status

Registration Date: Oct 02, 2024

About this record

Access comprehensive regulatory information for Spinal Column Stabilization Module in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2402652ĐKLH/BYT-HTTB and manufactured by Globus Medical, Inc. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN VIỆT - SING MEDICAL.

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