BI-Mentum PE Liner

BI-MENTUM dual mobility system -BI-MENTUM PE Liner polyethylene liner

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

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MEH
Manufacturer City Province Registered as Device types
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
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54

Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Record

Regulatory record for BI-Mentum PE Liner
Listed by SOC Etudes Recherches Fabrication
FDA product code MEH
Device type Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class Class 2
Regulation 21 CFR 888.3353
Record published 2019-01-15

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for BI-Mentum PE Liner
Catalogue number Size Status
BI-MENTUM PE Liner 22,2 / 49 In distribution
BI-MENTUM PE Liner 28 / 69 In distribution
BI-MENTUM PE Liner 22,2 / 57 In distribution
BI-MENTUM PE Liner 22,2 / 61 In distribution
BI-MENTUM PE Liner 22,2 / 41 In distribution
BI-MENTUM PE Liner 22,2 / 69 In distribution
BI-MENTUM PE Liner 28 / 49 In distribution
BI-MENTUM PE Liner 28 / 53 In distribution
BI-MENTUM PE Liner 28 / 57 In distribution
BI-MENTUM PE Liner 28 / 61 In distribution
BI-MENTUM PE Liner 22,2 / 45 In distribution
BI-MENTUM PE Liner 22,2 / 53 In distribution
BI-MENTUM PE Liner 22,2 / 65 In distribution
BI-MENTUM PE Liner 28 / 65 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Alteon Exactech, Inc. 326
Novation Exactech, Inc. 317
Pinnacle Depuy Orthopaedics, Inc. 305
SP-CL Hip Stem Waldemar Link GmbH & Co. KG 219
Emperion Smith & Nephew, Inc. 201
MobileLink Acetabular Cup System Waldemar Link GmbH & Co. KG 154
Instrument Howmedica Osteonics Corp 145
Restoration Howmedica Osteonics Corp 144
Mfinity Femoral System Medacta International SA 138
Echelon Smith & Nephew, Inc. 134
Trinity Acetabular Hip System Corin Limited 128
Redapt Smith & Nephew, Inc. 127

Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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