Vietnam MOH registration 2400471ĐKLH/BYT-HTTB

Spinal Column Screw Set

VN: Bộ vít cột sống

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Globus Medical, Inc·Registered Apr 10, 2024

Registration details

Analysis ID: 2400471ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210814-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Globus Medical, Inc
Manufacturer Country: Theo theo phụ lục
Product Owner: Globus Medical, Inc
Authorized Representative: CÔNG TY CỔ PHẦN VIỆT - SING MEDICAL

Technical details

Intended Use: The REVLOK™ Cervical Pedicle Screw System, when used as a posterior-lateral cervical pedicle screw, is designed to stabilize the vertebrae in the adult human spine as a bone fusion device, used in the treatment of acute or chronic instability or deformity of the thoracic, lumbar and sacral spines: Degenerative disc disease, spondylolisthesis (Grade 3 and 4) at L5-S1 in the adult spine of a patient who has undergone spinal fusion with a bone graft and has an implant attached to the lumbar vertebrae and/or pelvis with the implant removed after the bone fusion was completed. The levels of fixation with these patients are L3-lumbar and/or pelvis. When used as a thoracolumbar anterior external fixation system, the REVLOK™ Fenestrated Screw System is designed to be used in conjunction with anterior fixation screws (with or without a compression screw) for the treatment of: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformity, fractures or dislocations of the thoracic and/or lumbar vertebrae, tumor resection, and/or failed spinal fusion. The levels of fixation with the REVLOK™ Cervical Pedicle Screws include a hole at the distal end to allow for the injection of bone cement, radiopaque dye, or saline. These holes can also facilitate bone growth into the screw. The injection of bone cement will enhance the fixation of the screw in weak and osteoporotic bone. The radiopaque dye and saline can be used to facilitate the placement of the screw and to avoid damage to the spinal canal.

Dates and status

Registration Date: Apr 10, 2024

About this record

Access comprehensive regulatory information for Spinal Column Screw Set in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2400471ĐKLH/BYT-HTTB and manufactured by Globus Medical, Inc. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN VIỆT - SING MEDICAL.

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