Medical device licence · 109848 · Class 3
COLINK NEOFUSE PLATING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 31, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109848
- Licence holder
- In2Bones UsaCordova, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 31, 2023
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTERIOR PLATE, LEFT, TRIAL, NON-STERILE
- ANTERIOR PLATE, RIGHT, TRIAL, NON-STERILE
- ANTERO-LATERAL, LEFT, TRIAL, NON-STERILE
- ANTERO-LATERAL, RIGHT, TRIAL, NON-STERILE
- COLAG SCREW
- COLAG SCREW, FT
- COLINK AFX LOCKING SCREW
- COLINK AFX LOW-PRO CORTICAL SCREW
- COLINK AFX VAL SCREW
- COLINK LOCKING SCREW
- COLINK LOW-PRO CORTICAL SCREW
- COLINK NEOFUSE PLATE, ANTERIOR
- COLINK NEOFUSE PLATE, ANTEROLATERAL
- COLINK VAL SCREW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.