Commission Implementing Regulation (EU) No 1214/2014
Of 11 November 2014 — CELEX 32014R1214
Description of the goods
A solid, cylindrical, threaded product (so-called ‘pangea dual core screw’) made of extra hard titanium alloy, of a length of between 20 and 45 mm. The shank is wholly threaded with a dual core thread containing a transition zone for the core diameter change. It is of a constant outer diameter of 4,0 mm, with a self-tapping profile and a blunt, threaded tip. The product has a polyaxial (movable) U-shaped, internally threaded head that offers 25° of angulation around its axis allowing its adjustment. The product has a specialised saddle in locking cap for fixing a rod (presented separately) in its head. The product corresponds to the ISO/TC 150 standards for implant screws and is presented for use in trauma surgery as a part of a system for posterior stabilisation of the spine. It is installed using specific tools. At importation, it is not presented in a sterilised packing. The product is marked with a number and therefore traceable throughout production and distribution. (*1) See image
Reasons
Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, note 2(b) to Chapter 90 and by the wording of CN codes 9021, 9021 10 and 9021 10 90. Due to its objective characteristics, namely the presence of the polyaxial U-shaped head with the locking cap, the product does not entirely correspond to a screw of base metal. Consequently, it cannot be considered a part of general use (screw) as referred to in note 2 to Section XV. Therefore, classification under heading 8108 is excluded. The product is therefore to be classified under CN code 9021 10 90 as splints and other fracture appliances.