Device Dossier
Comprehensive VRS Reaming Guide, Bone Model, and Implant Model - Custom-made anatomy model/surgical guide kit
Device Dossier for Comprehensive VRS Reaming Guide, Bone Model, and Implant Model - Custom-made anatomy model/surgical guide kit (Custom-made anatomy…
- GMDN category: Custom-made anatomy model/surgical guide kit
Intended purpose
A collection of non-sterile, patient-matched devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of anatomic model(s) of an organ/bone and an orthopaedic surgical guide(s) [e.g., for osteotomy, arthroplasty]; manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.