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"Ximei" bone metal shoulder artificial humeral backbone - Taiwan Registration 5e4a376417336f5db555bc6b20b7aefd

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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5e4a376417336f5db555bc6b20b7aefd
Registration Details
Taiwan FDA Registration: 5e4a376417336f5db555bc6b20b7aefd
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Device Details

"Ximei" bone metal shoulder artificial humeral backbone
TW: โ€œ่ฅฟ็พŽโ€้ชจ้‡‘ๅฑฌ่‚ฉ้ƒจไบบๅทฅ่‚ฑ้ชจ้ชจๅนน
Risk Class 2
Cancelled

Registration Details

5e4a376417336f5db555bc6b20b7aefd

DHA00601841101

Company Information

United States

Product Details

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.

N Orthopedics

N.3650 Non-restrictive shoulder joints, metals/polymers, cements, and supplements

import

Dates and Status

Aug 08, 2007

Aug 08, 2017

Nov 04, 2019

Cancellation Information

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