Device Dossier

Orthopaedic fixation plate kit, non-biodegradable

Device Dossier for Orthopaedic fixation plate kit, non-biodegradable (Orthopaedic fixation plate kit, non-biodegradable, Class IIb, sponsor Materialise).…

Intended purpose

CMF Titanium Guides, Plates and Implants are intended to transfer a preoperative plan to surgery. CMF Titanium Implants can be used in combination with a CMF Titanium Guides for predrilling the fixation screws. CMF Titanium Guides are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. The CMF Titanium Plates can be used in combination with a CMF Titanium Guides for predrilling the fixation screws.

TGA Public Summary