Medical device licence · 74606 · Class 2
3DX MANDIBULAR DISTRACTOR
Yes: licensed in Canada
Licence status Issued (active); first licensed August 2, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 74606
- Licence holder
- Kls Martin L.P.Jacksonville, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 2, 2007
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3DX EXTERNAL MANDIBULAR DISTRACTOR SYSTEM - ARM
- 3DX EXTERNAL MANDIBULAR DISTRACTOR SYSTEM - CARBON FIBER ROD
- 3DX EXTERNAL MANDIBULAR DISTRACTOR SYSTEM - CARBON ROD FIXATION CLAMP
- 3DX EXTERNAL MANDIBULAR DISTRACTOR SYSTEM - GEAR ONLY
- 3DX EXTERNAL MANDIBULAR DISTRACTOR SYSTEM - PIN HOLDING CLAMP
- 3DX EXTERNAL MANDIBULAR DISTRACTOR SYSTEM - PIN HOLDING CLAMP
- 3DX EXTERNAL MANDIBULAR DISTRACTOR SYSTEM - PIN HOLDING CLAMP SCREW
- 3DX EXTERNAL MANDIBULAR DISTRACTOR SYSTEM - STAND
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.