Cervical Anterior Spinal Column Plate and Screws - Vietnam Registration 2403363ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2403363ĐKLH/BYT-HTTB
000.00.04.G18-230713-0002
Theo theo phụ lục
Theo phụ lục
Technical Details
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
Nov 06, 2024