Baumer Ortopedia , Ltd.

Baumer Ortopedia, Ltd. specializes in orthopedic fixation devices. Their product line includes intramedullary systems designed for stabilizing long bones, metal plates used to secure bone fragments during fracture repair, staples for approximating soft tissue or bone, pins for internal fixation, and screws for aligning and securing bone fragments. These devices are engineered to support surgical interventions in orthopedic procedures.

Baumer Ortopedia, Ltd. is based in the United States. Their devices are registered for use in the U.S., where they are subject to regulatory oversight by the FDA. Registration ensures compliance with local medical device regulations, allowing for distribution and use within the country.

Baumer Ortopedia, Ltd.’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as orthopedic fixation hardware. Class II devices typically require premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device.

Baumer Ortopedia, Ltd.’s devices are listed via the FDA’s 510(k) pathway. This pathway is used for Class II devices to demonstrate that a new device is at least as safe and effective as a legally marketed predicate device already on the market. The 510(k) process ensures that the company’s products meet regulatory requirements before being authorized for commercial distribution in the U.S.