Vietnam MOH registration 240000582/PCBA-HCM

The Kit for Installing Double-threaded Screws for the Lumbar Thoracic Spine

VN: Bộ dụng cụ lắp đặt nẹp vít ren đôi cột sống lưng ngực

Vietnam·Risk Class TTBYT Loại A·Theo theo phụ lục·NuVasive, Inc.·Registered Apr 12, 2024

Registration details

Analysis ID: 240000582/PCBA-HCM
Submission ID: 000.00.19.H29-240408-0005
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: NuVasive, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: NuVasive, Inc.
Authorized Representative: CÔNG TY CỔ PHẦN TRANG THIẾT BỊ Y TẾ CỔNG VÀNG

Technical details

Intended Use: The dual-threaded spinal rod fixation kit is used to fix the spinal rod in adult patients, indicated to provide stability and fixation of the supporting spinal segments for the bone fusion process after instability, loss of stability, or deformity of the posterior spine like the thoracic, lumbar, and sacral vertebrae in various conditions: + Disc degeneration + Neurogenic instability with nerve damage + Fracture + Dislocation + Kyphosis + Scoliosis + Spinal tumor + Previous failed surgery (prosthetic joint) It is contraindicated for use in the fixation of the spinal rod in pediatric patients, and the system is indicated for bone fusion in the treatment of idiopathic scoliosis. Additionally, it is used to treat pediatric patients with vertebral slippage and fractures due to tumor or trauma. The fixation of the spinal rod in pediatric patients is limited by the posterior approach and the use of bone grafting. The kit is indicated for the fixation of the spinal rod in patients with severe slippage (grades 3 and 4) at the L5-S1 level in adults, who achieve bone fusion by autografting and have spinal and sacral fixation (L3-sacrum) and the removal of the implanted rod after achieving bone fusion.

Dates and status

Registration Date: Apr 12, 2024

About this record

Access comprehensive regulatory information for The Kit for Installing Double-threaded Screws for the Lumbar Thoracic Spine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000582/PCBA-HCM and manufactured by NuVasive, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN TRANG THIẾT BỊ Y TẾ CỔNG VÀNG.

This page provides complete technical specifications, regulatory compliance details. 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.