Medical device licence · 92922 · Class 3
G7 ACETABULAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 6, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 92922
- Licence holder
- Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet TraumaWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 6, 2014
- Devices covered
- 32
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- G7 ACETABULAR LINER, ARCOMXL HIGHLY CROSSLINKED
- G7 ACETABULAR LINER, E1 ANTIOXIDANT INFUSED TECHNOLOGY
- G7 ACETABULAR LINER: ARCOMXL / 10 DEGREE FACE CHANGING
- G7 ACETABULAR LINER: ARCOMXL / HIGH WALL
- G7 ACETABULAR LINER: ARCOMXL / NEUTRAL
- G7 ACETABULAR LINER: E1 / 10 DEGREE FACE CHANGING
- G7 ACETABULAR LINER: E1 / HIGH WALL
- G7 ACETABULAR LINER: E1 / NEUTRAL
- G7 ACETABULAR LINER: FREEDOM CONSTRAINED / NEUTRAL
- G7 ACETABULAR SCREW
- G7 ACETABULAR SHELL - 3 HOLE POROUS PLASMA BONEMASTER, CEMENTLESS
- G7 ACETABULAR SHELL - 3 HOLE POROUS PLASMA, CEMENTLESS
- G7 ACETABULAR SHELL 3 HOLE OSSEOTI, CEMENTLESS
- G7 ACETABULAR SHELL MULTI HOLE OSSEOTI, CEMENTLESS
- G7 APICAL HOLE PLUG
- G7 FINNED ACETABULAR SHELL 3 HOLE POROUS PLASMA, CEMENTLESS
- G7 FINNED ACETABULAR SHELL 3 HOLE POROUS PLASMA/BONEMASTER, CEMENTLESS
- G7 FINNED ACETABULAR SHELL 4 HOLE POROUS PLASMA, CEMENTLESS
- G7 FINNED ACETABULAR SHELL 4 HOLE POROUS PLASMA/BONEMASTER, CEMENTLESS
- G7 FREEDOM ACETABULAR LINER, E1 ANTIOXIDANT INFUSED TECHNOLOGY
- G7 POLY LINER REMOVAL SCREW
- G7 PROVISIONAL 10 DEGREE FACE CHANGING LINER
- G7 PROVISIONAL FREEDOM CONSTRAINED LINER
- G7 PROVISIONAL FREEDOM LINER
- G7 PROVISIONAL HIGH WALL LINER
- G7 PROVISIONAL NEUTRAL LINER
- G7 PROVISIONAL SHELL
- G7 PROVISIONAL TRAY KITS
- G7 SCREW HOLE PLUG
- G7 SUCTION CUP (NON-STERILE)
- G7 SUCTION CUP (STERILE)
- G7 TYPE 12/14 PROVISIONAL HEAD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.