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Vít đa trục rỗng nòng bơm xi măng - Vietnam Registration 2403098ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Vít đa trục rỗng nòng bơm xi măng 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 2403098ĐKLH/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, 2 companies making similar products including Medtronic Puerto Rico Operations, Co., Nuvasive, Inc, and 5 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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2403098ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403098ĐKLH/BYT-HTTB
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Device Details

Vít đa trục rỗng nòng bơm xi măng
CD HORIZON SOLERA Fenestrated Screw Spinal System
Risk Class TTBYT Loại C

Registration Details

2403098ĐKLH/BYT-HTTB

17001733/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Medtronic Plc

Technical Details

Purpose: The CD HORIZON™ SOLERA™ Intramedullary Cement-Fillable Multiaxial Screw is an adjunct to the CD HORIZON™ Spinal Fixation System and is intended to be used as a support component for the healing process of the thoracic, lumbar, or sacral vertebrae. Indications: The CD HORIZON™ SOLERA™ Intramedullary Cement-Fillable Multiaxial Screw is indicated for use in the fixation of the spine, excluding the cervical spine, from the posterior approach to support the healing process for the following conditions: degenerative disc disease (DDD - when determined to be the cause of low back pain based on the patient's history and confirmed by the radiographic findings), degenerative spondylolisthesis, fracture (i.e., a broken bone or dislocation), spinal stenosis, scoliosis, kyphosis, or lordosis, tumor, arthroplasty, and/or failure of a prior bone grafting procedure. When used in combination with the Cement-Fillable Multiaxial Screw, the CD HORIZON™ SOLERA™ Intramedullary Cement-Fillable Multiaxial Screw is indicated to enhance the fixation of the spinal cord in patients with compromised/bone deficient vertebrae.

Dates and Status

Nov 02, 2024

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