Medical device licence · 110141 · Class 3
MEDACTA SHOULDER SYSTEM (ANATOMIC)
Yes: licensed in Canada
Licence status Issued (active); first licensed October 6, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110141
- Licence holder
- Medacta International SaCastel San Pietro, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 6, 2023
- Devices covered
- 45
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CENTRAL PEG REAMER FOR PE GLENOID - 0.3 PRESS-FIT
- CENTRAL PEG REAMER FOR PEGGED GLENOID
- DOUBLE ECCENTER
- DOUBLE ECCENTER / REVERSE METAPHYSIS SCREW
- DRILL BIT FOR PERIPHERAL PEGS
- DRILL BIT FOR STEMLESS METAPHYSIS
- FLAT REAMER - CANNULATED
- FLAT REAMER - NOT CANNULATED
- GLENOID 3-BLADE REAMER
- GLENOID CENTRAL PEG DRILL BIT
- GLENOID REAMER
- GLENOID REAMER - HALF DESIGN
- GUIDING PLUG FOR GLENOID REAMERS
- HUMERAL ANATOMICAL METAPHYSIS-CEMENTED
- HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS
- HUMERAL HEAD - COBALT-CHROMIUM
- HUMERAL PLANAR CUTTER
- HUMERAL STEM SCREW
- LONG HUMERAL DIAPHYSIS
- MEDACTA SHOULDER SYSTEM DISPOSABLE K-WIRE
- MEDACTA SHOULDER SYSTEM DISPOSABLE PIN PACK
- MODULAR TREPHINE - CENTRAL PEG REAMER
- MODULAR TREPHINE - GRAFT REAMER
- MODULAR TREPHINE - K-WIRE ADAPTOR
- MONOBLOC GLENOID HALF REAMER
- MONOBLOC GLENOID REAMER
- MONOBLOCK GLENOID HALF REAMER
- OVAL GLENOID REAMER
- PE PEGGED GLENOID
- REAM AND RUN REAMERS
- REAMER FOR STEMLESS METAPHYSIS
- REAMER HANDLE
- SHORT HUMERAL DIAPHYSIS - CEMENTLESS
- STANDARD HUMERAL DIAPHYSIS - CEMENTED
- STANDARD HUMERAL DIAPHYSIS - CEMENTLESS
- TRIAL ANATOMIC METAPHYSIS
- TRIAL DOUBLE ECCENTER
- TRIAL ECCENTER FOR STEMLESS METAPHYSIS
- TRIAL GLENOID
- TRIAL HUMERAL DIAPHYSIS
- TRIAL HUMERAL HEAD CAP
- TRIAL HUMERAL HEAD DISH
- TRIAL HUMERAL LONG DIAPHYSIS
- TRIAL HUMERAL METAPHYSIS
- TRIAL HUMERAL SHORT DIAPHYSIS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.