Medical device licence · 13328 · Class 3
MALLORY HEAD HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 20, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 13328
- 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
- October 20, 1999
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MALLORY/HEAD ACETABULAR SHELL
- MALLORY/HEAD CALCAR DISTAL PROXIMAL
- MALLORY/HEAD CALCAR PROVISIONAL REPLACEMENT STEM
- MALLORY/HEAD COLLARLESS POROUS PRIMARY FEMORAL COMPONENT
- MALLORY/HEAD EXACT HIP INSTRUMENTATION STANDARD TRUNION
- MALLORY/HEAD EXACT PF BROACH
- MALLORY/HEAD HA COATED FEMORAL - TI
- MALLORY/HEAD HAP COATED FEMORAL PRIMARY STEM
- MALLORY/HEAD HIP SYSTEM - RINGLOC LINER
- MALLORY/HEAD HIP SYSTEM FOUR FINNED 3-HOLE RINGLOC SHELL
- MALLORY/HEAD LATERAL CLAW CONNECTOR
- MALLORY/HEAD RADIAL SHELL SOLID RINGLOC W/APICAL DOME HOLE POROUS COAT
- MALLORY/HEAD RH CALCAR DISTAL
- MALLORY/HEAD STANDARD PF PROVISIONAL
- MALLORY/HEAD TROCHANTER BOLT
- MALLORY/HEAD TROCHANTER PLATE
- MALLORY/HEAD-MODULAR CALCAR PROXIMAL FEMORAL REPLACEMENT
- MALLORY/HEAD-TROCHANTERIC CLAW
- RING-LOC ACETABULAR TRIAL SHELL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.