Medical device licence · 34255 · Class 3
BONE SCREWS - TITANIUM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 23, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 34255
- Licence holder
- Biomet MicrofixationJacksonville, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- November 23, 2001
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1.0MM SCREW
- 1.5MM SCREW
- 1.5MM SD THINFLAP SCREW
- 1.8MM THINFLAP EMERGENCY SCREW
- 2.0MM SCREW
- 2.0MM SD IMF SCREW
- 2.4MM (FRACTURE) SCREW
- 2.4MM CANCELLOUS SCREW
- 2.7MM (FRACTURE) SCREW
- 2.7MM CANCELLOUS SCREW
- ADD-ON CONDYLAR SCREW
- EMERGENCY STERNALOCK SCREW
- HIGH TORQUE SELF DRILLING CROSS DRIVE SCREW
- IMF SCREWS
- LOCKING RECON TISSUE INSERT
- LOCKING RECONSTRUCTION SCREW
- SCREW, 2.0 CROSS DRIVE
- SCREW, 2.0 CROSS DRIVE LOCKING
- SCREW, 2.0 SELF DRILLING
- SCREW, 2.3 CROSS DRIVE
- SCREW, 2.3 CROSS-DRIVE LOCKING
- SMALL FRAGMENT SCREW
- STERNALOCK SD SCREW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.