(87 days)
EUROSCREW® NG and EUROSCREW® NG TCP screws are indicated in knee anterior cruciate ligament reconstruction in ligamentoplasty procedures.
Teknimed's EUROSCREW® NG and EUROSCREW® TCP NG are bioabsorbable interference screws used in ligament surgery specifically designed for fixation of both bone-tendon-bone and soft tissue grafts. The screws are suitable and designed for ligamentoplasty surgical procedures specifically for knee anterior cruciate ligament reconstructions. Both are implantable screw devices in long term contact with bone and tissue grafts. Teknimed's EUROSCREW® NG and EUROSCREW® TCP NG are implant devices that are utilized in a surgical setting with a qualified healthcare professional (i.e., surgeons).
This is not an AI/ML device, therefore, the requested information is not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.