Medical device licence · 111282 · Class 2
ROSA HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 17, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111282
- Licence holder
- Orthosoft UlcMontreal, QC, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 17, 2024
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ROSA HIP ROSA CUP INSERTER ADAPTOR
- ROSA HIP ROSA CUP INSERTER HANDLE
- ROSA HIP ROSA CUP INSERTER SCREW
- ROSA HIP ROSA OFFST CUP INSERTER SHAFT
- ROSA HIP ROSA QUICK CONNECT INTERFACE
- ROSA HIP ROSA QUICK CONNECT SLEEVE
- ROSA HIP ROSA STRT CUP INSERTER SHAFT
- ROSA HIP ROSA TABLET
- ROSA HIP TABLET BATTERY
- ROSA HIP TABLET BATTERY BAY
- ROSA HIP TABLET POWER CORD TYPE (B)
- ROSA RECON OPTICAL UNIT
- ROSA RECON ROBOTIC UNIT 110V
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.