Vietnam MOH registration 2403363ĐKLH/BYT-HTTB

Cervical Anterior Spinal Column Plate and Screws

VN: Bộ nẹp, vít cột sống cổ lối trước

ZEVO Anterior Cervical Plate System

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Medtronic Plc·Registered Nov 06, 2024

Registration details

Analysis ID: 2403363ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230713-0002
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: The ZEVO Cervical Pedicle Screw System consists of temporary fixation components used to stabilize the adjacent vertebrae to the fusion joint in the cervical spine during the development process. The ZEVO™ Cervical Pedicle Screw System is implanted via the anterior approach. Indications: The ZEVO™ Cervical Pedicle Screw System is indicated for the stabilization of the anterior column from C2 to T1. The system is used to stabilize the anterior column temporarily in the development process of the cervical spine in patients with: 1) cervical disc degeneration, as determined by cervical disc pain, 2) trauma (including fractures), 3) tumors, 4) deformities, such as kyphosis, lordosis, or scoliosis, 5) cervical arthroplasty, and/or 6) failed anterior cervical fusion. This device is intended for use in the stabilization of the anterior column of the cervical spine. This device has not been cleared for use in the posterior elements (lamina) of the cervical, thoracic, or lumbar spine.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Cervical Anterior Spinal Column Plate and Screws 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 2403363ĐKLH/BYT-HTTB and manufactured by Medtronic Plc. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.

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