Serial No.

Name of the product

Classification code

Product Description

1

Titanium plate with pulling loops

6846

The product consists of titanium plates, coils and sutures. The titanium plate should be made of titanium alloy in accordance with ISO 5832-3 standard, and the suture is made of a polymer material. It is suitable for the fixation of ligament, tendon or bone in orthopedic reconstruction operations.

2

Orthopedic screws

6846

Such products are made of stainless steel, pure titanium and titanium alloy materials complying with requirements in ISO 5832-2, ASTM F899, ISO 5832-3 and ISO 5832-11 (excluding innovative processes such as 3D printing). The product is used alone for the limb bone fixation.

3

Filler rod

6846

The product is made of pure tantalum according to ISO 13782 (not including products produced with innovative processes such as 3D printing). The product is used alone for the filling of limb bones.

4

Plug for acetabular cups

6846

The product is made of titanium alloy Ti6Al4V according to the ISO 5832-3 standard. It is used for the filling of holes on acetabular cups.

5

Medullary plug

6846

This kind of products is made from ultra-high molecular weight polyethylene that meet the requirements of ISO 5834-2. It is used for bone cement prosthesis implantation and can prevent bone cement from overflowing into the medullary cavity area. The suitable application sites include femur, tibia and humerus medullary cavities.

6

Needless connecting piece

6866

The product is typically made up of connectors, fittings and tubing (optional). It is a connection component for non-puncture infusions. It is used with an intravascular indwelling catheter for blood vessel drug infusion and blood extraction. The waiver is not applicable to products with positive pressure performance using new materials, new active ingredients, new techniques or new designs or having new working mechanisms or new functions.