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“DePuy Synthes” VBS VERTEBRAL BODY STENTING SYSTEM - Taiwan Registration 1729fa1b9e982e49a22d7be9a5d3de9b

Access comprehensive regulatory information for “DePuy Synthes” VBS VERTEBRAL BODY STENTING SYSTEM in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1729fa1b9e982e49a22d7be9a5d3de9b and manufactured by SYNTHES GMBH. The authorized representative in Taiwan is JOHNSON & JOHNSON MEDICAL TAIWAN LTD..

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1729fa1b9e982e49a22d7be9a5d3de9b
Registration Details
Taiwan FDA Registration: 1729fa1b9e982e49a22d7be9a5d3de9b
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Device Details

“DePuy Synthes” VBS VERTEBRAL BODY STENTING SYSTEM
TW: “帝富信迪思”威比士椎體支架系統
Risk Class 2
MD

Registration Details

1729fa1b9e982e49a22d7be9a5d3de9b

Ministry of Health Medical Device Import No. 036505

DHA05603650505

Company Information

Switzerland

Product Details

The VBS system is designed to reduce painful vertebral compression fractures and/or the formation of voids in the loose bones of the spine to treat patients with skeletally mature development in the T5-L5 range. It is expected to be used in combination with a legally marketed bone cement containing PMMA for vertebroplasty or kyphoplasty procedures. Indications: (1) Painful vertebral compression fracture (no posterior vertebral wall fracture, Genant's second- and third-degree fractures) (2) Treatment of osteoporosis lesions in the vertebral body with pathological fractures (no erosion of the posterior vertebral wall, and must be Tomita type 1)

N Orthopedics

N3060 Spine correction fixation between vertebral bodies

Imported from abroad

Dates and Status

Sep 26, 2023

Sep 26, 2028