Biomendex OY

Biomendex OY specializes in bone grafting solutions. Their primary product, the Adaptos®Fuse Bone Graft, is designed specifically for spinal and orthopedic surgeries to support bone fusion and healing. This product is tailored for procedures where bone regeneration is required, such as in spinal fusions or orthopedic reconstructions.

Biomendex OY is based in the United States. Since the company operates within the U.S., its devices are subject to the regulatory framework of the FDA. The Adaptos®Fuse Bone Graft, for example, is listed under the FDA’s 510(k) pathway, which is a premarket submission required for Class II devices to demonstrate substantial equivalence to a legally marketed predicate device.

Biomendex OY’s devices, such as the Adaptos®Fuse Bone Graft, are listed under the FDA’s 510(k) pathway. This means the product has undergone the necessary regulatory review process to demonstrate compliance with U.S. medical device regulations. While the company itself isn’t listed in a broader registry, its devices are documented in the FDA’s database as part of the 510(k) clearance process.

The Adaptos®Fuse Bone Graft, Biomendex OY’s primary product, is classified as a Class II medical device. This classification is determined by the FDA based on the level of risk associated with the device. Class II devices generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements.