Taiwan FDA registration 4528a7ef1072dcac2e7bf0d9d20908be
Zimmer Fitness Artificial Knee Group
TW: “捷邁”耐適健人工膝關節組
Registration details
- Analysis ID
- 4528a7ef1072dcac2e7bf0d9d20908be
- Customs Code
- DHA00602138602
Company information
- Manufacturer
- ZIMMER,INC.
- Manufacturer Country
- United States
- Authorized Representative
- ZIMMER BIOMET TAIWAN CO., LTD.
Product details
- Intended Use
- ● This device is suitable for the following conditions of severe knee pain and disability: - Osteoarthritis. - Primary and secondary traumatic arthritis. - Avascular necrosis of the femoral malleolus. - Moderate valgus, varus, or flexion deformation (valgus/varus≦15. , fixed bending deformation ≦10. ). ● This device is only used for fixation with bone cement.
- Product Type (Level 1)
- N Orthopedics
- Import Information
- import
Dates and status
- Registration Date
- Sep 28, 2010
- Expiry Date
- Sep 28, 2015
- Cancellation Date
- May 28, 2018
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for Zimmer Fitness Artificial Knee Group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 4528a7ef1072dcac2e7bf0d9d20908be and manufactured by ZIMMER,INC.. The authorized representative in Taiwan is ZIMMER BIOMET TAIWAN CO., LTD..
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