Corin Bipolar Prosthesis

BIPOLAR EUROCONE TRIAL HEAD 49mm STANDARD

Registry build 21.09.26
14manufacturers in China registered for this device type
182catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWY
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
APS Materials Suzhou Suzhou Jiangsu Contract manufacturer 18
Xian Airfoil Technology Co., Ltd. Xian Shaanxi Contract manufacturer 8
Lincotek (Wuxi) Co., Ltd. Wuxi Jiangsu Contract manufacturer 7
b-ONE Medical (Beijing) Co., Ltd. Beijing Beijing Contract manufacturer 7
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70

Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Record

Regulatory record for Corin Bipolar Prosthesis
Listed by Corin Limited, United Kingdom
FDA product code KWY
Device type Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class Class 2
Regulation 21 CFR 888.3390
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K925897
Record published 2016-08-17
Record revised 2024-09-11 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Corin Bipolar Prosthesis
Catalogue number Size Status
S103.152 In distribution
111.957 In distribution
E211.849 In distribution
S103.148 In distribution
111.953 In distribution
E211.741 In distribution
E211.740 In distribution
E211.752 In distribution
E011.642 In distribution
E211.744 In distribution
E211.953 In distribution
E011.751 In distribution
E011.750 In distribution
E011.549 In distribution
E211.742 In distribution
E211.860 In distribution
E011.644 In distribution
E211.847 In distribution
E211.853 In distribution
E011.758 In distribution
E011.544 In distribution
E211.759 In distribution
E011.660 In distribution
E011.545 In distribution
E011.645 In distribution
E011.654 In distribution
E011.649 In distribution
E211.750 In distribution
111.946 In distribution
E211.859 In distribution
E211.938 In distribution
E211.838 In distribution
E011.554 In distribution
E211.943 In distribution
E011.744 In distribution
E211.751 In distribution
E011.757 In distribution
211.300 In distribution
E211.841 In distribution
E211.950 In distribution
E011.760 In distribution
211.303 In distribution
E011.743 In distribution
E011.648 In distribution
E011.651 In distribution
111.958 In distribution
E011.657 In distribution
E011.540 In distribution
S103.153 In distribution
S103.157 In distribution
E211.754 In distribution
S103.143 In distribution
E211.747 In distribution
E211.852 In distribution
E011.548 In distribution
E211.858 In distribution
E011.557 In distribution
E211.959 In distribution
S103.144 In distribution
E011.556 In distribution
S103.155 In distribution
E211.955 In distribution
E011.754 In distribution
E211.756 In distribution
111.940 In distribution
S103.146 In distribution
S103.159 In distribution
E011.558 In distribution
E211.850 In distribution
E211.755 In distribution
111.959 In distribution
111.949 In distribution
111.955 In distribution
E211.500 In distribution
E211.842 In distribution
E211.743 In distribution
E211.941 In distribution
E011.541 In distribution
E011.547 In distribution
E011.753 In distribution
E211.748 In distribution
E211.749 In distribution
E211.839 In distribution
E011.749 In distribution
111.942 In distribution
E211.949 In distribution
S103.149 In distribution
E200.126 In distribution
E211.845 In distribution
E011.546 In distribution
S103.141 In distribution
111.950 In distribution
E211.738 In distribution
E211.746 In distribution
E211.854 In distribution
E211.757 In distribution
E011.741 In distribution
E211.942 In distribution
111.944 In distribution
E011.640 In distribution
E211.840 In distribution
E211.745 In distribution
E011.555 In distribution
E211.948 In distribution
E211.958 In distribution
E011.742 In distribution
E011.646 In distribution
E011.755 In distribution
E011.560 In distribution
E211.951 In distribution
S103.147 In distribution
E211.739 In distribution
E211.857 In distribution
S103.140 In distribution
E211.758 In distribution
S103.154 In distribution
E200.226 In distribution
E011.643 In distribution
111.954 In distribution
E011.752 In distribution
E211.855 In distribution
E011.559 In distribution
E211.856 In distribution
E211.846 In distribution
E011.542 In distribution
111.960 In distribution
E211.851 In distribution
E011.659 In distribution
E200.026 In distribution
111.961 In distribution
E211.945 In distribution
111.952 In distribution
E011.759 In distribution
111.943 In distribution
E211.848 In distribution
E211.843 In distribution
E211.944 In distribution
E011.543 In distribution
E011.655 In distribution
E011.551 In distribution
E011.746 In distribution
E011.658 In distribution
S103.160 In distribution
111.941 In distribution
111.951 In distribution
E211.957 In distribution
E211.952 In distribution
E211.753 In distribution
E011.553 In distribution
E011.650 In distribution
E011.748 In distribution
S103.156 In distribution
E211.947 In distribution
E211.844 In distribution
E011.652 In distribution
S103.150 In distribution
E211.940 In distribution
E211.960 In distribution
E011.656 In distribution
E211.946 In distribution
111.945 In distribution
S103.142 In distribution
E011.745 In distribution
111.956 In distribution
E011.747 In distribution
S103.145 In distribution
E011.740 In distribution
E011.552 In distribution
E011.756 In distribution
111.947 In distribution
E211.954 In distribution
111.962 In distribution
E011.653 In distribution
S103.151 In distribution
E011.647 In distribution
E011.550 In distribution
E211.760 In distribution
E211.939 In distribution
111.948 In distribution
S103.158 In distribution
E211.956 In distribution
E011.641 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Resolve Modular Revision Hip Stem United Orthopedic Corp. 196
Consensus® Hip System Consensus Orthopedics, Inc. 177
Consensus Hip System Shalby Advanced Technologies, Inc. 177
Instrument Howmedica Osteonics Corp 130
Bencox Hip System Corentec Co., Ltd. 126
United Hip System, U2 Bipolar Implant United Orthopedic Corp. 123
MultiPolar® Zimmer, Inc. 100
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Zimmer, Inc. 96
Fitmore® Hip Stem Zimmer, Inc. 75
Arcos® Modular Revision System Biomet Orthopedics 67
Acumatch L-Series Exactech, Inc. 67
Corin BiPolar-i Corin Limited 54

Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer