Implantable craniofacial bone distractor expansion tool, home-use
19 devices GMDN 64610
An implantable craniofacial bone distractor expansion tool is a device used to gradually lengthen and expand the bones of the face and skull. It is typically used by patients in their own homes to make daily adjustments to an implanted device that is designed to progressively lengthen the bones over time.
These devices are designed for single-patient reuse and are intended for manual operation by a layperson. They are subject to regulatory oversight, and their supply and use are governed by relevant rules and guidelines.