ApprovalTrail

Medical device licence · 110222 · Class 3

MEDACTA SHOULDER SYSTEM (REVERSE)

Yes: licensed in Canada

Licence status Issued (active); first licensed October 25, 2023. It is in Health Canada’s list of active licences.
Licence number
110222
Licence holder
Medacta International SaCastel San Pietro, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
October 25, 2023
Devices covered
77

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • BASEPLATE CENTRAL PEG DRILL BIT
  • CENTRAL PEG REAMER FOR BASEPLATE
  • CENTRAL PEG REAMER FOR BASEPLATE
  • CENTRAL PEG REAMER FOR THREADED GLENOID BASEPLATE
  • CONICAL CENTRAL PEG REAMER FOR BASEPLATE
  • DRILL BIT
  • DRILL BIT FOR GLENOID POLYAXIAL SCREWS
  • DRILL BIT FOR GLENOID SCREWS
  • FLAT ANGLED REAMER
  • FLAT REAMER - CANNULATED
  • FLAT REAMER - NOT CANNULATED
  • GLENOID 3-BLADE REAMER
  • GLENOID BASEPLATE - PEGGED
  • GLENOID BASEPLATE - THREADED
  • GLENOID POLYAXIAL SCREW - LOCKING
  • GLENOID POLYAXIAL SCREW - NON-LOCKING
  • GLENOID REAMER
  • GLENOID REAMER - HALF DESIGN
  • GLENOSPHERE
  • GLENOSPHERE SCREW
  • GRAB CENTRAL PEG DRILL BIT
  • GRAB K-WIRE ADAPTER
  • GRS CENTRAL PEG REAMER
  • GRS DRIVING SHAFT
  • GRS FULL WEDGE HALF REAMER
  • GRS FULL WEDGE ONE-STEP REAMER
  • GRS FULL WEDGE REAMER
  • GRS FW ONE-STEP HALF REAMER
  • GRS LINE-TO-LINE CENTRAL PEG REAMER
  • GRS LINE-TO-LINE CENTRAL PEG REAMER
  • GRS LINE-TO-LINE CENTRAL PEG REAMER - SMALL
  • GRS MONOBLOCK CENTRAL PEG REAMER
  • GRS MONOBLOCK CENTRAL PEG REAMER - SMALL
  • GUIDING PLUG FOR GLENOID REAMERS
  • HALF FLAT ANGLED REAMER
  • HUMERAL ECCENTRIC REVERSE METAPHYSIS
  • HUMERAL PLANAR CUTTER
  • HUMERAL REVERSE METAPHYSIS - FLAT
  • HUMERAL REVERSE METAPHYSIS - RV CORRECTED
  • HUMERAL REVERSE PE LINER - HIGHCROSS
  • LATERALIZED GLENOSPHERE
  • 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
  • MODULAR TREPHINE - SLIM GRAFT REAMER
  • MONOBLOC CENTRAL PEG REAMER
  • MONOBLOC CENTRAL PEG REAMER FOR BASEPLATE
  • MONOBLOC CENTRAL PEG REAMER FOR RSA
  • MONOBLOC CENTRAL PEG REAMER FOR THREADED
  • MONOBLOC CENTRAL PEG REAMER FOR TSA
  • MONOBLOC GLENOID REAMER
  • MONOBLOC GLENOID+GLENOSPHERE REAMER
  • MONOBLOC STARTER DRILL - CANNULATED - AO
  • MONOBLOC STARTER DRILL - NOT CANNULATED
  • MONOBLOCK GLENOID HALF REAMER
  • NEXTAR REAMER SHAFT
  • NOZZLED GLENOID REAMER
  • POLYAXIAL SCREWDRIVER - MODULAR TIP
  • REAMER FOR STEMLESS METAPHYSIS
  • REAMER HANDLE
  • REVERSE METAPHYSIS REAMER
  • SMALL REVERSE METAPHYSIS REAMER
  • THREADED BASEPLATE CENTRAL PEG DRILL BIT
  • TRIAL GLENOSPHERE
  • TRIAL ECCENTRIC REVERSE METAPHYSIS
  • TRIAL HUMERAL DIAPHYSIS
  • TRIAL HUMERAL DIAPHYSIS FOR RSA
  • TRIAL HUMERAL LONG DIAPHYSIS
  • TRIAL HUMERAL LONG DIAPHYSIS FOR RSA
  • TRIAL HUMERAL REVERSE LINER
  • TRIAL HUMERAL SHORT DIAPHYSIS
  • TRIAL HUMERAL SHORT DIAPHYSIS FOR RSA
  • TRIAL LAT GLENOSPHERE
  • TRIAL REVERSE HUMERAL LINER
  • TRIAL REVERSE METAPHYSIS W/GROOVES

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.