Taiwan FDA registration 1729fa1b9e982e49a22d7be9a5d3de9b

“DePuy Synthes” VBS VERTEBRAL BODY STENTING SYSTEM

TW: “帝富信迪思”威比士椎體支架系統

Taiwan·Risk Class 2·MD·SYNTHES GMBH·Registered Sep 26, 2023 – Sep 26, 2028Active

Registration details

Analysis ID: 1729fa1b9e982e49a22d7be9a5d3de9b
License Form: Ministry of Health Medical Device Import No. 036505
Customs Code: DHA05603650505

Company information

Manufacturer: SYNTHES GMBH
Manufacturer Country: Switzerland
Authorized Representative: JOHNSON & JOHNSON MEDICAL TAIWAN LTD.

Product details

Intended Use: 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)
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N3060 Spine correction fixation between vertebral bodies
Import Information: Imported from abroad

Dates and status

Registration Date: Sep 26, 2023
Expiry Date: Sep 26, 2028

About this record

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..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.