Medical device licence · 74982 · Class 3
PRODISC-C TOTAL DISC REPLACEMENT
Yes: licensed in Canada
Licence status Issued (active); first licensed October 2, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 74982
- Licence holder
- Centinel Spine, LlcWest Chester, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 2, 2007
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MILLING BIT - STERILE
- MILLING BIT HXC-STERILE
- MILLING BIT WITH FLAT COUPLING - STERILE
- MILLING BIT WITH SHAFT-STERILE
- PRODISC-C
- TRIAL IMPLANT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.