LİNACOL MEDİKAL A.Ş.

Lınacol Medical A.Ş. specializes in sterile bone cement formulations, including variants tailored for vertebroplasty (20g and 40g), general orthopedic procedures (20g and 40g), and cranioplasty (20g and 40g). Additionally, the company produces the DeFix and KIBO devices, which serve distinct orthopedic and surgical purposes. These products are designed for procedures involving bone stabilization, spinal interventions, and cranial reconstruction.

Lınacol Medical A.Ş. is based in Turkey. Its devices are registered in the EUDAQMED database, which is the official European Union registry for medical devices. This registration ensures transparency and compliance with EU regulatory requirements for devices marketed within the region.

The devices produced by Lınacol Medical A.Ş. fall under Class IIa and Class IIb classifications according to EU medical device regulations. These classifications are determined based on factors like the risk associated with the device’s use, its intended purpose, and the potential harm it may pose to patients. Class IIa devices pose a moderate risk, while Class IIb devices carry a higher risk, requiring stricter regulatory oversight.

The DeFix and KIBO devices are part of Lınacol Medical A.Ş.’s portfolio and are designed for specific surgical applications. While the exact details of their intended use are not provided, these devices are likely engineered to assist in orthopedic procedures, potentially for bone fixation, stabilization, or other specialized surgical needs. Their classification as Class IIa or Class IIb indicates they are subject to regulatory scrutiny due to their role in critical medical interventions.