Cervical Spine Surgery Fixation Plate, Screws, Rods, Hooks, and Locking Covers - Vietnam Registration 2400475ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Cervical Spine Surgery Fixation Plate, Screws, Rods, Hooks, and Locking Covers 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 2400475ĐKLH/BYT-HTTB and manufactured by Aesculap AG. The authorized representative in Vietnam is CÔNG TY TNHH B. BRAUN VIỆT NAM.
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Device Details
Registration Details
2400475ĐKLH/BYT-HTTB
19008322/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
The Ennovate Cervical Spinal Fusion System is used to stabilize one or more segments of the cervical-cervical joint, cervical spine, and upper thoracic spine. The system consists of: •Cervical pedicle screw and rod •Longitudinal rod •Multilevel screw •Locking nut •Hook •Transverse connecting rod (head-head or longitudinal-longitudinal) •Other connectors •Cervical contouring plate The cervical contouring plate Ennovate is designed for use in the cervical spine (C3-C6) after a unilateral contouring plate surgery has been performed. It is secured to the contouring plate through SecureSpan screws. Spinal fusion surgery is intended to support the healing process and is not a substitute for normal body structure or permanent load support in the case of non-healing. Contouring plate surgery should be used in conjunction with other fixation devices (e.g., bone grafting). Appropriate fusion materials from the Ennovate Spinal System (such as the rod) may also be used. Special tools are required to implant these components and to perform thoracic-lumbar distraction procedures.
Dates and Status
Apr 10, 2024

