Medical device licence · 95776 · Class 2
X-GUIDE SURGICAL NAVIGATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 15, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95776
- Licence holder
- X-Nav Technologies, Llc.Lansdale, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 15, 2015
- Devices covered
- 34
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BONE SCREW
- E-CLIP
- FASTMAP NAVIGATED PHOTOGRAMMETRY
- GO-PLATE
- HANDPIECE ASSEMBLY TOOL
- HANDPIECE CALIBRATION DISK
- HANDPIECE CONNECTOR ASSEMBLY
- HANDPIECE TRACKER
- ICONIX AI
- PATIENT TRACKER
- PROBE TOOL
- PROBE TRACKER
- SAFETY GLASSES
- SCREWDRIVER
- TRACKER ARM
- WRENCH
- X-CLIP
- X-GUIDE ADAPTER SLEEVE
- X-GUIDE BONE SCREW AND NUT, EDX
- X-GUIDE EDENTULOUS KIT
- X-GUIDE EDX NUT DRIVER
- X-GUIDE EDX PILOT KIT
- X-GUIDE HANDPIECE ADAPTOR ASM
- X-GUIDE INSTRUMENT KIT
- X-GUIDE REGION KIT - NORTH AMERICA
- X-GUIDE STRAIGHT HANDPIECE CALIBRATION BIT
- X-GUIDE SURGICAL NAVIGATION SYSTEM
- X-GUIDE TRACKER ARM ASSEMBLY, CLX
- X-GUIDE TRACKER ARM ASSEMBLY, EDX
- X-GUIDE TRACKER ARM ASSEMBLY, EDX-C
- X-GUIDE X-MARK PROBE TOOL
- X-MARK LICENSE
- XOS PLANNING SOFTWARE - MACOS
- XOS PLANNING SOFTWARE - MS WINDOWS
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “x-guide”. A notice may cover another product or only some lots: read it to see what it covers.
- X-Guide X-Mark Probe ToolOctober 19, 2022 · Dental · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.