Discectomy and Screw - Vietnam Registration 2400446ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2400446ĐKLH/BYT-HTTB
000.00.04.G18-210305-0003
Theo theo phụ lục
Theo phụ lục
Technical Details
-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
Apr 10, 2024