Device Dossier
Custom-made anatomy model/surgical guide kit
Device Dossier for Custom-made anatomy model/surgical guide kit (Custom-made anatomy model/surgical guide kit, Class IIa, sponsor Materialise). ARTG…
- GMDN category: Custom-made anatomy model/surgical guide kit
Intended purpose
CMF Plastic Guides and CMF Orthognatic Splints are intended to be used as surgical tools to transfer a preoperative plan to surgery. CMF Plastic Guides are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. CMF Orthognatic Splints are intended to align the maxilla and/or mandible in orthognathic surgical procedures. The subject devices are intended for single use only.