Vietnam MOH registration 2400475ĐKLH/BYT-HTTB

Cervical Spine Surgery Fixation Plate, Screws, Rods, Hooks, and Locking Covers

VN: Bộ nẹp, vít, thanh, móc và nắp khóa trong phẫu thuật cột sống cổ

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Aesculap AG·Registered Apr 10, 2024

Registration details

Analysis ID: 2400475ĐKLH/BYT-HTTB
Submission ID: 19008322/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Aesculap AG
Manufacturer Country: Theo theo phụ lục
Product Owner: Aesculap AG
Authorized Representative: CÔNG TY TNHH B. BRAUN VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Apr 10, 2024

About this record

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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