Taiwan FDA registration 0d9e402dddd5a1477b300e8b30e18414

"Seame-Dumit" bone metal vertebral gasket

TW: “西美-杜密特”骨金屬椎狀墊片

Taiwan·Risk Class 2·ZIMMER TRABECULAR METAL TECHNOLOGY, INC.·Registered Aug 16, 2007 – Aug 16, 2017Cancelled

Registration details

Analysis ID: 0d9e402dddd5a1477b300e8b30e18414
Customs Code: DHA00601841700

Company information

Manufacturer: ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
Manufacturer Country: United States
Authorized Representative: ZIMMER BIOMET TAIWAN CO., LTD.

Product details

Intended Use: Trabecular Metal Tibial and Femoral Cone is used for the reconstruction of a knee defect due to severe degeneration, trauma, or other knee lesions, as well as for the correction or remediation of previous knee reconstructive procedures and implants. When used with the Rotational Articulated Knee (RHK) System in the NexGen Knee System, the bone metal tibial vertebrae and femoral vertebral spacers can only be applied in a cemented manner, and when used with the LOCK system in the NexGen Knee System, they can be applied in a cemented or cemented manner.
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N.3565 Knee jointsFemoral metals/polymersPorous coatings of cementless cement
Import Information: import

Dates and status

Registration Date: Aug 16, 2007
Expiry Date: Aug 16, 2017
Cancellation Date: Nov 04, 2019

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Seame-Dumit" bone metal vertebral gasket in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0d9e402dddd5a1477b300e8b30e18414 and manufactured by ZIMMER TRABECULAR METAL TECHNOLOGY, INC.. The authorized representative in Taiwan is ZIMMER BIOMET TAIWAN CO., LTD..

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