Lumbar Disc Spacer Piece - Vietnam Registration 2403333ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Lumbar Disc Spacer Piece 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 2403333ĐKLH/BYT-HTTB and manufactured by Spineway SA. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN ĐẦU TƯ TUẤN NGỌC MINH.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Theo theo phụ lục, and 1 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
2403333ĐKLH/BYT-HTTB
000.00.04.G18-231222-0068
Theo theo phụ lục
Theo phụ lục
Technical Details
The Twin Peaks lumbar interbody fusion device is indicated for use in the treatment of adult patients with degenerative disc disease (DDD) of the lumbar spine, involving one or two adjacent vertebrae from L2-S1. Degenerative disc disease is defined as a condition of low back pain due to degeneration of the intervertebral disc, confirmed by history and radiographic studies. Patients with DDD may have a grade 1 spondylolisthesis or posterior migration at the involved vertebrae. The Twin Peaks lumbar interbody fusion device must be used in conjunction with autograft or allograft bone. The patient must have a mature skeleton and must have failed at least six months of non-surgical treatment. The Twin Peaks lumbar interbody fusion device must be used in conjunction with an additional fixation method in the lumbar spine.
Dates and Status
Nov 06, 2024