Medical device licence · 98236 · Class 2
VSP CRANIAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 15, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98236
- Licence holder
- 3D Systems, Inc.Littleton, CO, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 15, 2016
- Devices covered
- 29
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VSP CRANIAL - BONE GRAFT TEMPLATE
- VSP CRANIAL - BONE OSTEOTOMY GUIDE
- VSP CRANIAL - BONE OSTEOTOMY MARKING GUIDE
- VSP CRANIAL - BONE OSTEOTOMY TEMPLATE
- VSP CRANIAL - BONE POSITIONING WEDGE
- VSP CRANIAL - BONE REPOSITIONING GUIDE
- VSP CRANIAL - CRANIAL CUTTING GUIDE
- VSP CRANIAL - CRANIAL MARKING GUIDE
- VSP CRANIAL - CRANIAL POSITIONING GUIDE
- VSP CRANIAL - DISTRACTOR DRILLING GUIDE
- VSP CRANIAL - DISTRACTOR MARKING GUIDE
- VSP CRANIAL - DRILL GUIDE
- VSP CRANIAL - FULL SKULL MODEL
- VSP CRANIAL - GRAFT PRE-CONTOURING TEMPLATE
- VSP CRANIAL - IMPLANT TEMPLATE
- VSP CRANIAL - METAL SLOT
- VSP CRANIAL - MIRRORED ANATOMICAL MODEL
- VSP CRANIAL - ORIGINAL ANATOMICAL MODEL
- VSP CRANIAL - PERFECTED ANATOMICAL MODEL
- VSP CRANIAL - PERFECTED FULL SKULL MODEL
- VSP CRANIAL - RECONSTRUCTED ANATOMICAL MODEL
- VSP CRANIAL - RECONSTRUCTED FULL SKULL MODEL
- VSP CRANIAL - REPOSITIONED ANATOMICAL MODEL
- VSP CRANIAL - REPOSITIONED FULL SKULL MODEL
- VSP CRANIAL - RESECTION GUIDE
- VSP CRANIAL - SURGICAL POSITIONING GUIDE
- VSP CRANIAL - SURGICAL POSITIONING TEMPLATE
- VSP CRANIAL - TRAUMA DRILLING GUIDE
- VSP CRANIAL - TRAUMA POSITIONING GUIDE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.