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China NMPA legacy archive 国械注准20243131632

Shoulder joint prosthesis

肩关节假体
Tianjin Zhengtian Medical Instrument Co., Ltd.Class IIINMPAApproved August 27, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class III
Approval department
State Drug Administration
国家药品监督管理局
Registration information
Registration number
国械注准20243131632
Approval date
August 27, 2024
Expiry date
August 26, 2029
Registrant
Name
Tianjin Zhengtian Medical Instrument Co., Ltd.
天津正天医疗器械有限公司
Province/Region
Tianjin
天津
Address
No. 318, Jingyi Road, Tianjin Airport Economic Zone
天津空港经济区经一路318号
Production facility
Production address
天津空港经济区经一路318号
Intended use
English

This product is an upright shoulder joint prosthesis, which is used in conjunction with bone cement and is suitable for shoulder replacement.

中文

该产品为正置型肩关节假体,与骨水泥配合使用,适用于肩关节置换。

Structure and composition
English

The shoulder prosthesis consists of the humeral stem, glenoid, and humeral head. The humeral shank is made of forged Ti6Al4V titanium alloy according to ISO 5832-3 and has a coating on the proximal surface made of pure titanium that meets the requirements of ASTM F1580. The glenoid is made of type II ultra-high molecular weight polyethylene according to ISO 5834-2 with developing filaments made of forged Ti6Al4V titanium alloy according to ISO 5832-3. The humeral head is made of a wrought cobalt-chromium-molybdenum alloy material that meets the requirements of ISO 5832-12. The product is sterilized by gamma irradiation, and the sterilization validity period is 5 years.

中文

肩关节假体由肱骨柄、关节盂、肱骨头组成。肱骨柄由符合ISO 5832-3标准规定的锻造Ti6Al4V钛合金材料制成,近端表面带有符合ASTM F1580标准要求的纯钛材料制成的涂层。关节盂由符合ISO 5834-2标准规定的II型超高分子量聚乙烯材料制成,带有符合ISO 5832-3标准规定的锻造Ti6Al4V钛合金材料制成的显影丝。肱骨头由符合ISO 5832-12标准规定的锻造钴铬钼合金材料制成。产品采用伽玛射线辐照灭菌,灭菌有效期5年。

Additional information
Remark
无。
Appendix
产品技术要求
About this record

This static archive preserves historical registration fields and translations for Shoulder joint prosthesis, registration 国械注准20243131632. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.