Corin Unipolar Modular Head

Unipolar MOD Heads

Registry build 21.09.26
10manufacturers in China registered for this device type
36catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWL
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Xian Airfoil Technology Co., Ltd. Xian Shaanxi Contract manufacturer 8
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34

Record

Regulatory record for Corin Unipolar Modular Head
Listed by Corin Limited, United Kingdom
FDA product code KWL
Device type Prosthesis, Hip, Hemi-, Femoral, Metal
Device class Class 2
Regulation 21 CFR 888.3360
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K063791
Record published 2016-08-17
Record revised 2020-04-06 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation 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 Unipolar Modular Head
Catalogue number Size Status
576-05-346 In distribution
576-04-244 In distribution
576-03-242 In distribution
576-05-046 In distribution
576-06-148 In distribution
576-07-350 In distribution
576-10-156 In distribution
576-07-050 In distribution
576-08-352 In distribution
576-10-256 In distribution
576-07-150 In distribution
576-02-040 In distribution
576-04-344 In distribution
576-06-348 In distribution
576-05-246 In distribution
576-09-354 In distribution
576-05-146 In distribution
576-07-250 In distribution
576-03-342 In distribution
576-10-356 In distribution
576-03-042 In distribution
576-08-052 In distribution
576-10-056 In distribution
576-02-240 In distribution
576-06-048 In distribution
576-08-152 In distribution
576-02-340 In distribution
576-09-054 In distribution
576-09-254 In distribution
576-08-252 In distribution
576-04-144 In distribution
576-04-044 In distribution
576-03-142 In distribution
576-09-154 In distribution
576-06-248 In distribution
576-02-140 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ustar II Knee System United Orthopedic Corp. 115
Consensus Hip System Shalby Advanced Technologies, Inc. 95
Consensus® Hip System Consensus Orthopedics, Inc. 95
Instrument Howmedica Osteonics Corp 94
UHR Howmedica Osteonics Corp 75
Austin Moore Howmedica Osteonics Corp 67
B-P Total HIP System Endotec, Inc. 66
CS2 Acetabular Cup System Consensus Orthopedics, Inc. 64
DJO Surgical Encore Medical, L.P. 62
Restoration Howmedica Osteonics Corp 56
Optimom Modular Heads Corin Limited 49
Perfecta Microport Orthopedics Inc. 35

Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal

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