Medical device licence · 109852 · Class 3
COLINK AFX PLATING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 2, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109852
- Licence holder
- In2Bones UsaCordova, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 2, 2023
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COLINK AFX CANCELLOUS SCREW
- COLINK AFX LATERAL FIBULA PLATE, LEFT
- COLINK AFX LATERAL FIBULA PLATE, RIGHT
- COLINK AFX LOCKING SCREW
- COLINK AFX LOW-PRO CORTICAL SCREW
- COLINK AFX MEDIAL TIBIA PLATE
- COLINK AFX ONE-THIRD TUBULAR PLATE
- COLINK AFX POSTERIOR TIBIA PLATE, LEFT
- COLINK AFX POSTERIOR TIBIA PLATE, RIGHT
- COLINK AFX POSTEROLATERAL FIBULA PLATE, LEFT
- COLINK AFX POSTEROLATERAL FIBULA PLATE, RIGHT
- COLINK AFX VAL SCREW
- COLINK AFX WASHER
- LATERAL FIBULA PLATE, LEFT, TRIAL, NON-STERILE
- LATERAL FIBULA PLATE, RIGHT, TRIAL, NON-STERILE
- MEDIAL TIBIA PLATE, TRIAL, NON-STERILE
- ONE-THIRD TUBULAR PLATE, TRIAL, NON-STERILE
- POSTERIOR TIBIA PLATE, LEFT, TRIAL, NON-STERILE
- POSTERIOR TIBIA PLATE, RIGHT, TRIAL, NON-STERILE
- POSTEROLATERAL FIBULA PLATE, LEFT, TRIAL, NON-STERILE
- POSTEROLATERAL FIBULA PLATE, RIGHT, TRIAL, NON-STERILE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.