Device, Prosthesis Alignment

Which Manufacturers in China Make This?

6 manufacturers in China hold an FDA registration for this device type, concentrated in Fujian, Beijing and Guangdong, and 2 other provinces. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Baoji Shengtaike Industry & Trade Co., Ltd. Shanxi, contract manufacturer
Foshan Hongfeng Co., Ltd. Guangdong, contract manufacturer
Fujian Guozi Rehabilitation Medical Co., Ltd. Fujian
Huae Trade Technology Co., Ltd. Beijing, contract manufacturer
Orthotech Rehabilitation Co., Ltd. Fujian
T&L (Jiaxing) Co., Ltd. Zhejiang

What Is FDA Product Code IQO?

Device, Prosthesis Alignment is FDA product code IQO, Class 1, 21 CFR 890.3025.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2007. None was by a company in China. The root cause the FDA records most often is Device Design (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Device, Prosthesis Alignment

SiloLiner, Pin, 4″X 14″

Catalogue number 1465, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

LA Liner, Pin, Uniform,6mm, Large+

2 catalogue numbers from 18117, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Duragel Pin Liner, Uniform, 3mm, XLarge

Catalogue number 18215, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Duragel Pin Liner, Tapered, 6mm, Large

Catalogue number 18208, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

SiloLiner, Pin, 3″X 14″

Catalogue number 1464, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

SiloLiner, Pin, 5″X 12″

Catalogue number 1462, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

LA Liner, Pin, Uniform, 9mm, Large

Catalogue number 18115, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Duragel Pin Liner, Uniform, 6mm, XLarge

Catalogue number 18205, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

LA Liner, Pin, U Niform, 9mm, Large+

Catalogue number 18118, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

SiloLiner, Pin, 3″X 12″

Catalogue number 1460, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Coapt Evaluation Kit

The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is an accessory intended to be used during the planning and…

Device, Prosthesis Alignment

LA Liner, Pin, Uniform, 6mm, XLarge

Catalogue number 18120, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

SiloLiner, Pin, 5″X 14″

Catalogue number 1466, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

SiloLiner, Pin, 4″X 12″

Catalogue number 1461, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

LA Liner, Pin, Uniform, 9mm, Medium

2 catalogue numbers from 18105, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

LA Liner, Pin, Uniform, 6mm, Medium+

2 catalogue numbers from 18109, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

LA Liner, Pin, Uniform, 3mm, Medium+

2 catalogue numbers from 18107, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Duragel,Pin Liner, Tapered, 6mm, Medium

2 catalogue numbers from 18206, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Torsion Adapter

Torsion Adapter, Pyramid Adapter to Pyramid Receiver, Ti

Device, Prosthesis Alignment

LA Liner, Pin, Tapered, 6mm, Medium

2 catalogue numbers from 18104, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Duragel Pin Liner, Uniform, 6mm, Medium+

2 catalogue numbers from 18202, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

LA Liner, Pin, Uniform, 3mm, XLarge

Catalogue number 18119, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Duragel Pin Liner, Uniform, 9mm, Large+

2 catalogue numbers from 18224, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Duragel Pin Liner, Uniform, 3mm, Large+

2 catalogue numbers from 18214, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

SiloLiner, Pin, 6″X 14″

Catalogue number 1467, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Juzo Bandaging Supplies

TheraPad, Nubbed

Device, Prosthesis Alignment

C100 Cylindrical Shuttle Lock

C100 Cylindrical Shuttle Lock Kit, with 1.5" Pin

Device, Prosthesis Alignment

Duragel Pin Liner, Tapered, 3mm, Medium+

2 catalogue numbers from 18217, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Juzo SoftCompress

SoftCompress Liner, Sheet, 125x100cm , L

Device, Prosthesis Alignment

LA Liner, Pin, Tapered, 3mm, Medium+

2 catalogue numbers from 18108, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

LA Liner, Pin, Uniform, 3mm, Large+

2 catalogue numbers from 18116, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Juzo Night

Juzo Night, Regular, Right , 3

Device, Prosthesis Alignment

SiloLiner, Pin, 6″X 12″

Catalogue number 1463, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Osseointegration Prosthetic Limb

5 mm Hex Distal Locking Screw - M10 Includes O-ring

Device, Prosthesis Alignment

Duragel Pin Liner, Uniform, 9mm, Medium

2 catalogue numbers from 18221, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Duragel Pin Liner, Uniform, 3mm, Medium+

2 catalogue numbers from 18212, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Duragel Pin Liner, Uniform, 6mm, Large

2 catalogue numbers from 18203, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

Device, Prosthesis Alignment

Endoskeletal Components

30mm Transfemoral Kit w/ Rotatable Pyramid Adapter w/ Pin-Lock Hole, Ti

Device, Prosthesis Alignment

LA Liner, Pin, Tapered, 9mm, Medium

2 catalogue numbers from 18105, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.

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