Device typeCustom-made organ/bone anatomy model/surgical guide kit: A collection of custom-made 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 an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is 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.
FDA categoryDriver, Wire, And Bone Drill, Manual, System, Image Processing, Radiological
Device ID00810007630861
Catalog numberZB-3D108
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information