Mikai s.p.a.

Mikai s.p.a. specializes in orthopaedic and traumatology fixation hardware. Their product range includes cortical and cancellous screws (both solid and cannulated), olive-tipped wires, dynamic fixation plates, supports for screws or wires, rapid clamps for fixation plates, and extension rods for intramedullary devices, particularly for tibial diaphyseal applications. These devices are designed to stabilize and secure bone fragments during surgical procedures.

Mikai s.p.a. is based in Italy. Their devices are developed and manufactured in compliance with EU Medical Device Regulations, ensuring adherence to strict quality, safety, and performance standards for surgical orthopaedic implants. This includes classification under the relevant EU regulatory framework.

Mikai s.p.a.’s devices are listed in the eudamed registry, which is the EU’s central database for medical devices. This registry ensures transparency and traceability of devices authorized under EU Medical Device Regulations, including those classified as Class I and Class IIb.

Mikai s.p.a.’s devices are classified under the EU Medical Device Regulations as either Class I (generally low-risk devices) or Class IIb (moderate-risk devices requiring additional scrutiny). Classification depends on factors like intended use, duration of contact with the body, and potential risks, ensuring appropriate regulatory oversight for each product.

Mikai s.p.a.’s fixation hardware is designed for orthopaedic and traumatology applications, specifically to stabilize and secure bone structures during surgical interventions. Their products, such as screws, plates, wires, and extension rods, are engineered to provide mechanical support, promote proper bone alignment, and aid in the healing process after fractures or trauma.