Bipolar Hip System

Bipolar Femoral Head Trial, 22mm, Sz 40

Registry build 21.09.26
21manufacturers in China registered for this device type
44catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWT
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5
Guangzhou Clean Medical Products Manufacturing Corp Guangzhou Guangdong Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 21. All 21 manufacturers in China registered for Template

Record

Regulatory record for Bipolar Hip System
Listed by Shalby Advanced Technologies, Inc., United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Contract manufacturer, Contract steriliser, Manufacturer
Premarket notification Exempt
Record published 2025-05-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Bipolar Hip System
Catalogue number Size Status
1914-1-2240 Bipolar Femoral Head Trial, 22mm, Sz 40 In distribution
1914-1-2256 Bipolar Femoral Head Trial, 22mm, Sz 56 In distribution
1914-0-0049 Bipolar Head Trial, 28 mm, Sz 49 In distribution
1914-0-0052 Bipolar Head Trial, 28 mm, Sz 52 In distribution
1914-1-2249 Bipolar Femoral Head Trial, 22mm, Sz 49 In distribution
1914-1-2238 Bipolar Femoral Head Trial, 22mm, Sz 38 In distribution
1914-0-0055 Bipolar Head Trial, 28 mm, Sz 55 In distribution
1914-0-0040 Bipolar Head Trial, 28 mm, Sz 40 In distribution
1914-1-2254 Bipolar Femoral Head Trial, 22mm, Sz 54 In distribution
1914-1-2239 Bipolar Femoral Head Trial, 22mm, Sz 39 In distribution
1914-0-0057 Bipolar Head Trial, 28 mm, Sz 57 In distribution
1914-1-2241 Bipolar Femoral Head Trial, 22mm, Sz 41 In distribution
1914-1-2243 Bipolar Femoral Head Trial, 22mm, Sz 43 In distribution
1914-0-0058 Bipolar Head Trial, 28 mm, Sz 58 In distribution
1914-0-0061 Bipolar Head Trial, 28 mm, Sz 61 In distribution
1914-1-2252 Bipolar Femoral Head Trial, 22mm, Sz 52 In distribution
1914-0-0041 Bipolar Head Trial, 28 mm, Sz 41 In distribution
1914-1-2245 Bipolar Femoral Head Trial, 22mm, Sz 45 In distribution
1914-1-2248 Bipolar Femoral Head Trial, 22mm, Sz 48 In distribution
1914-0-0038 Bipolar Head Trial, 28 mm, Sz 38 In distribution
1914-1-2251 Bipolar Femoral Head Trial, 22mm, Sz 51 In distribution
1914-1-2242 Bipolar Femoral Head Trial, 22mm, Sz 42 In distribution
1914-0-0044 Bipolar Head Trial, 28 mm, Sz 44 In distribution
1914-0-0062 Bipolar Head Trial, 28 mm, Sz 62 In distribution
1914-1-2244 Bipolar Femoral Head Trial, 22mm, Sz 44 In distribution
1914-0-0048 Bipolar Head Trial, 28 mm, Sz 48 In distribution
1914-0-0043 Bipolar Head Trial, 28 mm, Sz 43 In distribution
1914-0-0051 Bipolar Head Trial, 28 mm, Sz 51 In distribution
1914-0-0059 Bipolar Head Trial, 28 mm, Sz 59 In distribution
1914-1-2253 Bipolar Femoral Head Trial, 22mm, Sz 53 In distribution
1914-0-0054 Bipolar Head Trial, 28 mm, Sz 54 In distribution
1914-1-2247 Bipolar Femoral Head Trial, 22mm, Sz 47 In distribution
1914-1-2246 Bipolar Femoral Head Trial, 22mm, Sz 46 In distribution
1914-0-0039 Bipolar Head Trial, 28mm, Size 39 In distribution
1914-1-2250 Bipolar Femoral Head Trial, 22mm, Sz 50 In distribution
1914-0-0050 Bipolar Head Trial, 28 mm, Sz 50 In distribution
1914-0-0056 Bipolar Head Trial, 28 mm, Sz 56 In distribution
1914-1-2255 Bipolar Femoral Head Trial, 22mm, Sz 55 In distribution
1914-0-0060 Bipolar Head Trial, 28 mm, Sz 60 In distribution
1914-0-0046 Bipolar Head Trial, 28 mm, Sz 46 In distribution
1914-0-0045 Bipolar Head Trial, 28 mm, Sz 45 In distribution
1914-0-0042 Bipolar Head Trial, 28 mm, Sz 42 In distribution
1914-0-0053 Bipolar Head Trial, 28 mm, Sz 53 In distribution
1914-0-0047 Bipolar Head Trial, 28 mm, Sz 47 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Attune Depuy (Ireland) 1,385
Template Exactech, Inc. 1,277
4WEB Medical 4WEB Inc. 991
Evolution® Microport Orthopedics Inc. 966
Template Zimmer, Inc. 792
Advance® Microport Orthopedics Inc. 644
Apex Knee System Omni Life Science, Inc. 635
Profemur® Microport Orthopedics Inc. 591
Link Instruments – Trial implants and size gauges Waldemar Link GmbH & Co. KG 549
Template Synthes Gmbh 516
Optetrak Logic Exactech, Inc. 512
Template Depuy Spine, Inc. 451

Showing 12 of 2,940. All products under Template

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