Lumbar Disc Spacer Piece
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Spineway SA·Registered Nov 06, 2024- Analysis ID
- 2403333ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231222-0068
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Spineway SA
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Spineway SA
- Authorized Representative
- CÔNG TY CỔ PHẦN ĐẦU TƯ TUẤN NGỌC MINH
- Intended Use
- 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.
- Registration Date
- Nov 06, 2024
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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.
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