Taiwan FDA registration da93113c7815488ec640e7b5e77b613b
"Boltai" polyetheretherketone cervical intervertebral fusion device
TW: “博爾泰”聚醚醚酮頸椎椎間融合器
Taiwan·Risk Class 2·A-SPINE Asia Co., Ltd.·Registered Dec 22, 2016 – May 26, 2021CancelledRegistration details
- Analysis ID
- da93113c7815488ec640e7b5e77b613b
Company information
- Manufacturer
- A-SPINE Asia Co., Ltd.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Boltai GmbH
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- N Orthopedics
- Product Type (Level 2)
- N.3080 椎體間融合裝置
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Dec 22, 2016
- Expiry Date
- May 26, 2021
- Cancellation Date
- Oct 06, 2023
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for "Boltai" polyetheretherketone cervical intervertebral fusion device in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number da93113c7815488ec640e7b5e77b613b and manufactured by A-SPINE Asia Co., Ltd.. The authorized representative in Taiwan is Boltai GmbH.
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