Vietnam MOH registration 2400446ĐKLH/BYT-HTTB

Discectomy and Screw

VN: Miếng ghép đĩa đệm và vít

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Centinel Spine, LLC·Registered Apr 10, 2024

Registration details

Analysis ID: 2400446ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210305-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Centinel Spine, LLC
Manufacturer Country: Theo theo phụ lục
Product Owner: Centinel Spine, LLC
Authorized Representative: CÔNG TY TNHH TRANSMEDIC HEALTHCARE

Technical details

Intended Use: -Stalif C and Stalif C Ti are used as a spinal fusion implant to facilitate spinal fusion as an independent system, combined with the accompanying bone screws, without the need for any additional support system. It is inserted between the vertebrae into the intervertebral disc space at one or two levels from C2/C3 to C7/T1 to treat cervical disc degeneration (defined as neck pain of confirmed disc degeneration origin, as determined by the patient's medical history and X-rays). The implant is designed to be used with autograft bone and/or allograft bone, including soft bone graft / or hard bone graft, to facilitate bone healing. -The intervertebral disc implant is intended for use in patients who have developed full bone healing and who have not been treated with bone grafting for at least 6 weeks. -The bone screws used to fix the Stalif C, Stalif C-Ti and Stalif C FLX implants to the adjacent vertebrae.

Dates and status

Registration Date: Apr 10, 2024

About this record

Access comprehensive regulatory information for Discectomy and Screw 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 2400446ĐKLH/BYT-HTTB and manufactured by Centinel Spine, LLC. The authorized representative in Vietnam is CÔNG TY TNHH TRANSMEDIC HEALTHCARE.

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