ALPHAMET LTD

Alphamet Ltd produces a range of medical devices primarily focused on orthopaedic applications. Their portfolio includes reusable sterilization and disinfection containers for medical devices, single-use fluted surgical drill bits (non-sterile), non-bioabsorbable sterile orthopaedic bone screws, implant aiming/guiding block attachment tools, and reusable surgical screwdrivers. These devices are designed to support surgical procedures, particularly in orthopaedics.

Alphamet Ltd is based in the United States. Since they operate domestically, their devices must comply with U.S. regulatory requirements for medical device authorisation, including those set by the FDA. Their products are also listed in the FDA’s Unique Device Identification (UDI) database, which helps ensure traceability and regulatory transparency for their Class II devices.

Alphamet Ltd’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry is used to track and identify medical devices in the U.S., ensuring compliance with regulatory standards and improving transparency for healthcare providers and authorities.

Alphamet Ltd’s devices fall under Class II classification by regulatory standards. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The specific controls applied depend on the device’s intended use and potential risks, as outlined in the relevant regulatory guidelines.