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VSP Orthopedics
A physical template that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
Details
Device typeCustom-made orthopaedic/craniofacial surgical guide: A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically 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.
FDA categoryOrthopaedic Surgical Planning And Instrument Guides
Device ID00816847022156
AvailabilityPrescription
Single useYes
MRI safetyMR Unsafe