Medical device licence · 460 · Class 3
S-ROM TOTAL HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 15, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 460
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 15, 1998
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- S-ROM TOTAL HIP SYSTEM - 11/13 TAPER HEADS
- S-ROM TOTAL HIP SYSTEM - A-ST ANDERSON THREADED CUP
- S-ROM TOTAL HIP SYSTEM - ARTHROPOR I ACETABULAR CUP
- S-ROM TOTAL HIP SYSTEM - ARTHROPOR III ACETABULAR CUP
- S-ROM TOTAL HIP SYSTEM - CALCAR REPLACEMENT FEMORAL STEM
- S-ROM TOTAL HIP SYSTEM - DOME SCREW
- S-ROM TOTAL HIP SYSTEM - FEMORAL HEADS
- S-ROM TOTAL HIP SYSTEM - FEMORAL STEM
- S-ROM TOTAL HIP SYSTEM - LATERALIZED CALCAR REPLACEMENT STEM 4 & 8MM
- S-ROM TOTAL HIP SYSTEM - LATERALIZED FEMORAL STEM
- S-ROM TOTAL HIP SYSTEM - LOCKING PIN
- S-ROM TOTAL HIP SYSTEM - PERIPHERAL SCREW
- S-ROM TOTAL HIP SYSTEM - POLY-DIAL INSERT CONSTRAINED X-RAY INDICATING
- S-ROM TOTAL HIP SYSTEM - POLY-DIAL INSERT NON-CONSTRAINED X-RAY INDICATING
- S-ROM TOTAL HIP SYSTEM - SPA COATED CONE SLEEVE
- S-ROM TOTAL HIP SYSTEM - SPT PROX THREADED SLEEVE
- S-ROM TOTAL HIP SYSTEM - TROCANTER WASHER
- S-ROM TOTAL HIP SYSTEM - TROCHANTER SCREW
- S-ROM TOTAL HIP SYSTEM - ZT HA PROXIMAL SLEEVE
- S-ROM TOTAL HIP SYSTEM - ZT PROXIMAL SLEEVE
- S-ROM TOTAL HIP SYSTEM - ZTT PROXIMAL SLEEVE
- S-ROM TOTAL HIP SYSTEM POLY-DIAL INSERT 3MM LAT. NON-CONSTRAINED X-RAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.