Medical device licence · 87907 · Class 3
PRO-FIX PRECISION FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 23, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 87907
- Licence holder
- Osteogenics Biomedical, Inc.Lubbock, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 23, 2011
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRO-FIX PRECISION FIXATION SYSTEM - BONE FIXATION KIT
- PRO-FIX PRECISION FIXATION SYSTEM - BONE FIXATION SCREWS
- PRO-FIX PRECISION FIXATION SYSTEM - DRIVER BLADE
- PRO-FIX PRECISION FIXATION SYSTEM - DRIVER HANDLE
- PRO-FIX PRECISION FIXATION SYSTEM - MEMBRANE FIXATION KIT
- PRO-FIX PRECISION FIXATION SYSTEM - MEMBRANE FIXATION SCREWS
- PRO-FIX PRECISION FIXATION SYSTEM - TENTING KIT
- PRO-FIX PRECISION FIXATION SYSTEM - TENTING SCREWS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.