Vietnam MOH registration 2402747ĐKLH/BYT-HTTB

Longitudinal Cervical Support

VN: Nẹp dọc cổ sau

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·MEDICREA INTERNATIONAL S.A.·Registered Oct 02, 2024

Registration details

Analysis ID: 2402747ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220421-0028
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: MEDICREA INTERNATIONAL S.A.
Manufacturer Country: Theo theo phụ lục
Product Owner: MEDICREA INTERNATIONAL S.A.
Authorized Representative: CÔNG TY TNHH MEDTRONIC VIỆT NAM

Technical details

Intended Use: The individual lateral plates used for each patient are implantable devices designed to contribute to the correction and stabilization of the cervical spine after the C6-C7 and high thoracic segments, extending from the C6 to T3 segments. These devices are not used in the lower thoracic (T4-T12), lumbar, and sacral regions. These implantable devices are designed to stabilize the spine during the process of achieving the normal, strong bone fusion. Indications: The individual lateral plates used for each patient are used in combination with different spinal fixation components of the spinal fixation system to promote the fusion of the C6-C7 and upper thoracic segments of the spine (C6-T3). The intended indications are as follows: 1. Degenerative disc disease. 2. Spondylolisthesis. 3. Failed previous fusion (prosthetic joint) 4. Narrowing of the spinal canal. 5. Trauma (fracture/ dislocation). 6. Fracture of the axis/atlanto (axis/ atlas) with instability. 7. Cervical and upper thoracic spine surgery on a previously operated segment. 8. Tumor These indications may reflect the underlying neurological disorder, spinal cord disorder, or combined neurological and spinal cord disorder.

Dates and status

Registration Date: Oct 02, 2024

About this record

Access comprehensive regulatory information for Longitudinal Cervical Support 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 2402747ĐKLH/BYT-HTTB and manufactured by MEDICREA INTERNATIONAL S.A.. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.

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.