Taiwan FDA registration 5e4a376417336f5db555bc6b20b7aefd

"Ximei" bone metal shoulder artificial humeral backbone

TW: “西美”骨金屬肩部人工肱骨骨幹

Taiwan·Risk Class 2·ZIMMER, INC.·Registered Aug 08, 2007 – Aug 08, 2017Cancelled

Registration details

Analysis ID: 5e4a376417336f5db555bc6b20b7aefd
Customs Code: DHA00601841101

Company information

Manufacturer: ZIMMER, INC.
Manufacturer Country: United States
Authorized Representative: Taiwan Zimmer Medical Device Co., Ltd

Product details

Intended Use: The indication for this subject as a replacement is severe pain or significant functional impairment of the shoulder joint with degeneration, rheumatoid or trauma; Humeral head fractures that have not healed for a long time; 3- or 4-part proximal humeral fracture that cannot be reduced; avascular necrosis of the femoral head; or other clinically difficult to deal with problems, unable to undergo arthrodesis or resectional joint replacement. This combination of humeral objects can be used alone during hemiarthroplasty or with socket components during total shoulder arthroplasty, including rotational muscle defects that do not allow for arthrodesis or traditional non-restrictive arthroplasty.
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N.3650 Non-restrictive shoulder joints, metals/polymers, cements, and supplements
Import Information: import

Dates and status

Registration Date: Aug 08, 2007
Expiry Date: Aug 08, 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 "Ximei" bone metal shoulder artificial humeral backbone in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5e4a376417336f5db555bc6b20b7aefd and manufactured by ZIMMER, INC.. The authorized representative in Taiwan is Taiwan Zimmer Medical Device Co., Ltd.

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