ApprovalTrail

Medical device licence · 79904 · Class 3

UNIVERS SHOULDER PROSTHESIS SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed June 5, 2009. It is in Health Canada’s list of active licences.
Licence number
79904
Licence holder
Arthrex IncNaples, FL, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 5, 2009
Devices covered
177

Devices on this licence

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

  • ANATOMIC SECONDARY GLENOID IMPACTOR
  • ANGLED REAMER SLEEVE
  • ANGLED REAMER, ORIENTATION SLEEVE
  • ARTHREX UNIVERS AND ECLIPSE HEAD IMPACTOR
  • ARTHREX UNIVERS II HUMERAL BROACH WITH SLOT
  • ARTHREX UNIVERS II, TRIAL STEM SCREW
  • ARTHREX UNIVERS REVERS , REAMER GUIDE
  • ARTHREX UNIVERS REVERS GLENOSPHERE INSERTER
  • ARTHREX UNIVERS REVERS HUMERAL LINER IMPACTOR
  • ARTHREX UNIVERS REVERS VERSION ROD
  • BASEPLATE EXTRACTOR
  • BASEPLATE INSERTER
  • BASEPLATE INSERTER CANNULATED
  • BASEPLATE, HALF AUGMENT SIZER
  • BONE GRAFT REAMER
  • BROACH, PEGGED GLENOID
  • CENTRAL POST EXTRACTOR
  • CENTRAL POST/SCREW TREPHINE ADAPTER
  • CENTRAL SCREW TAP, UNIVERS REVERS
  • CTA CUT GUIDE
  • DEPTH STOP
  • FULL AUGMENT DEPTH GAUGE
  • GLENOID SCRAPETTE
  • GLENOSPHERE DISTRACTOR
  • GLENOSPHERE INSERTER
  • GLENOSPHERE SIZING GUIDE
  • GUIDE PIN DEPTH GAUGE
  • HALF AUGMENT DEPTH GAUGE
  • HUMERAL CUP REAMER
  • HUMERAL CUP SCREW GUIDE
  • HUMERAL CUT PROTECTOR PLATE
  • HUMERAL RESECTION TEMPLATE
  • INFERIOR GLENOID REAMER
  • INTRAMEDULLARY HUMERAL CUTTING GUIDE
  • MODULAR HANDLE
  • OVER BASEPLATE REAMER
  • PERIPHERAL REAMER
  • PERIPHERAL SCREW DEPTH GAUGE
  • PIN GUIDE
  • PIN KIT, UNIVERS REVERS MODULAR GLENOID SYSTEM
  • PIN SET, UNIVERS II / ECLIPSE TOTAL SHOULDER ARTHROPLASTY SYSTEMS
  • PRESSURIZER, PEGGED GLENOID
  • PUNCH, PEGGED GLENOID
  • QUICK CONNECT DRIVE SHAFT
  • RETRACTOR ANGLED
  • REVISION CTA CUT GUIDE
  • SPEED GUIDE, NON-LOCKING SCREW
  • STEM / CUP EXTRACTOR ADAPTER HANDLE, UNIVERS REVERS
  • TAP
  • THREADED BASEPLATE INSERTER, AUGMENTED MODULAR GLENOID SYSTEM
  • TORQUE INDICATING ADAPTER
  • TREPHINE ADAPTER, AUGMENTED MODULAR GLENOID SYSTEM
  • TRIAL COMBINATION INSERT
  • TRIAL CUP
  • TRIAL HUMERAL INSERT
  • TRIAL HUMERAL SPACER
  • UNIVERS APEX HUMERAL BROACH
  • UNIVERS APEX HUMERAL BROACH ALIGNMENT GUIDE
  • UNIVERS APEX OPTIFIT HUMERAL STEM
  • UNIVERS APEX PROTECTOR POST
  • UNIVERS II / ECLIPSE HUMERAL RESECTION BLOCK
  • UNIVERS II TITANIUM HUMERAL HEAD
  • UNIVERS REVERS APEX HUMERAL STEM
  • UNIVERS REVERS CA ADAPTER TRIAL
  • UNIVERS REVERS CA HUMERAL HEAD
  • UNIVERS REVERS CA HUMERAL HEAD ADAPTER
  • UNIVERS REVERS CA HUMERAL HEAD TRIAL
  • UNIVERS REVERS CENTRAL SCREW TAP FOR UNIVERSAL BASEPLATE IMPACTOR
  • UNIVERS REVERS FRACTURE ADAPTER
  • UNIVERS REVERS FRACTURE ADAPTER EXTRACTOR
  • UNIVERS REVERS FRACTURE ADAPTER EXTRACTOR SHAFT
  • UNIVERS REVERS FRACTURE ADAPTER IMPACTOR
  • UNIVERS REVERS FRACTURE ADAPTER TRIAL
  • UNIVERS REVERS FRACTURE ADAPTER, TRUNION
  • UNIVERS REVERS GLENOID GLENOSPHERE EXTRACTOR
  • UNIVERS REVERS GLENOID VERSION GUIDE
  • UNIVERS REVERS GLENOSPHERE, TRIAL
  • UNIVERS REVERS HUMERAL BROACH
  • UNIVERS REVERS HUMERAL CUP SCREW GUIDE
  • UNIVERS REVERS HUMERAL IMPACTOR / EXTRACTOR ADAPTER
  • UNIVERS REVERS HUMERAL RESECTION DOWNROD
  • UNIVERS REVERS HUMERAL RESECTION GUIDE
  • UNIVERS REVERS HUMERAL RESECTION SLIDE BLOCK
  • UNIVERS REVERS HUMERAL STEM, MODULAR
  • UNIVERS REVERS MODULAR GLENOID SYSTEM COMBO HUMERAL INSERT
  • UNIVERS REVERS MODULAR GLENOID SYSTEM CONSTRAINED COMBO HUMERAL INSERT
  • UNIVERS REVERS MODULAR GLENOID SYSTEM DRILL BIT
  • UNIVERS REVERS MODULAR GLENOID SYSTEM HUMERAL INSERT
  • UNIVERS REVERS MONOBLOCK STEM
  • UNIVERS REVERS REAMER GUIDE
  • UNIVERS REVERS REAMER GUIDE 135
  • UNIVERS REVERS REAMER GUIDE, MODULAR
  • UNIVERS REVERS REPLACEMENT CUP SCREW
  • UNIVERS REVERS SPACER
  • UNIVERS REVERS SUPEROLATERAL HUMERAL RESECTION GUIDE
  • UNIVERS REVERS SUPEROLATERAL VERSION ADAPTER
  • UNIVERS REVERS SUTURECUP
  • UNIVERS REVERS SYSTEM - GLENOSPHERE
  • UNIVERS REVERS SYSTEM - HUMERAL INSERT
  • UNIVERS REVERS SYSTEM - SPACER
  • UNIVERS REVERS SYSTEM - STEM
  • UNIVERS REVERS SYSTEM - SUTURECUP
  • UNIVERS REVERS SYSTEM - TRIAL CUP
  • UNIVERS REVERS SYSTEM - TRIAL GLENOSPHERE
  • UNIVERS REVERS SYSTEM - TRIAL INSERT
  • UNIVERS REVERS SYSTEM - TRIAL SPACER
  • UNIVERS REVERS SYSTEM - TRIAL STEM
  • UNIVERS REVERS TRIAL STEM
  • UNIVERS REVERS UNIVERSAL BASEPLATE IMPACTOR
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM, GLENOSPHERE SCREW
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM, PERIPHERAL SCREWS, NON-LOCKING
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: AUGMENTED BASEPLATE POSTS
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: AUGMENTED BASEPLATES, OBLIQUE
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: GLENOID BASEPLATES
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: GLENOSPHERES, COCR
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: GLENOSPHERES, TITANIUM
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: HUMERAL INSERTS
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: NON-AUGMENTED BASEPLATE POSTS
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: NON-AUGMENTED BASEPLATE SCREWS
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: PERIPHERAL SCREWS, LOCKING
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: STANDARD, AUGMENTED GLENOID BASEPLATES
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: TRIAL AUGMENT BASEPLATES
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: TRIAL GLENOSPHERES
  • UNIVERS REVERSE MODULAR GLENOID SYSTEM: TRIAL HUMERAL INSERTS
  • UNIVERS SHOULDER SYSTEM - CTA HUMERAL HEAD TRIAL
  • UNIVERS SHOULDER SYSTEM - DRILL GLOVE PROTECTOR
  • UNIVERS SHOULDER SYSTEM - DRIVER, TRIAL HEAD
  • UNIVERS SHOULDER SYSTEM - GLENOID DRILL GUIDE
  • UNIVERS SHOULDER SYSTEM - GLENOID KEEL PUNCH
  • UNIVERS SHOULDER SYSTEM - GLENOID POLY WITH KEEL
  • UNIVERS SHOULDER SYSTEM - GLENOID REAMER SHAFT, ANGLED
  • UNIVERS SHOULDER SYSTEM - GLENOID RETRACTOR
  • UNIVERS SHOULDER SYSTEM - GLENOID SCREWDRIVER
  • UNIVERS SHOULDER SYSTEM - GLENOID WITH PEG
  • UNIVERS SHOULDER SYSTEM - HANDLE FOR DRILLING TEMPLATE
  • UNIVERS SHOULDER SYSTEM - HEAD EXTRACTOR
  • UNIVERS SHOULDER SYSTEM - HEAD IMPACTOR
  • UNIVERS SHOULDER SYSTEM - HUMERAL HEAD
  • UNIVERS SHOULDER SYSTEM - IMPACTOR GLENOID
  • UNIVERS SHOULDER SYSTEM - IMPACTOR, POINTED
  • UNIVERS SHOULDER SYSTEM - ORIENTATION PIN FOR RESECTION GUIDE
  • UNIVERS SHOULDER SYSTEM - QUICK RELEASE DRILL
  • UNIVERS SHOULDER SYSTEM - RASP
  • UNIVERS SHOULDER SYSTEM - REAMER, GLENOID
  • UNIVERS SHOULDER SYSTEM - REAMER, HUDSON CONNECT
  • UNIVERS SHOULDER SYSTEM - RESECTION PROTECTOR
  • UNIVERS SHOULDER SYSTEM - RESECTION PROTECTOR FOR TRIAL SHAFT
  • UNIVERS SHOULDER SYSTEM - SCREWDRIVER
  • UNIVERS SHOULDER SYSTEM - SLAPHAMMER
  • UNIVERS SHOULDER SYSTEM - STEM
  • UNIVERS SHOULDER SYSTEM - STEM EXTRACTOR
  • UNIVERS SHOULDER SYSTEM - STEM EXTRACTOR
  • UNIVERS SHOULDER SYSTEM - STEM IMPACTOR
  • UNIVERS SHOULDER SYSTEM - STEM IMPACTOR
  • UNIVERS SHOULDER SYSTEM - TORQUE DRIVER
  • UNIVERS SHOULDER SYSTEM - TRIAL GLENOID
  • UNIVERS SHOULDER SYSTEM - TRIAL HEAD
  • UNIVERS SHOULDER SYSTEM - TRIAL HEAD CONNECTOR
  • UNIVERS SHOULDER SYSTEM - TRIAL STEM
  • UNIVERS SHOULDER SYSTEM - TRIAL TRUNION FOR TRIAL HEAD
  • UNIVERS SHOULDER SYSTEM - TRUNION EXTRACTOR
  • UNIVERS SHOULDER SYSTEM - TRUNION KIT
  • UNIVERS SHOULDER SYSTEM - UNIVERS CA HEAD
  • UNIVERS SHOULDER SYSTEM - UNIVERSAL GLENOID BASEPLATE
  • UNIVERS SHOULDER SYSTEM - UNIVERSAL GLENOID CENTRAL SCREW
  • UNIVERS SHOULDER SYSTEM - UNIVERSAL GLENOID PERIPHERAL SCREW
  • UNIVERS SHOULDER SYSTEM - VAULTLOCK GLENOID
  • UNIVERS VAULTLOCK & KEEL GLENOID PIN GUIDE, QUICK CONNECT
  • UNIVERS VAULTLOCK AUGMENTED GLENOID ANGLED REAMER SLEEVE
  • UNIVERS VAULTLOCK AUGMENTED GLENOID ANGLED REAMER SLEEVE DEPTH STOP
  • UNIVERS VAULTLOCK AUGMENTED GLENOID BROACH
  • UNIVERS VAULTLOCK AUGMENTED GLENOID BROACH BASE
  • UNIVERS VAULTLOCK AUGMENTED GLENOID PIN GUIDE
  • UNIVERS VAULTLOCK GLENOID INSERTER / IMPACTER
  • UNIVERS VAULTLOCK GLENOID INSERTER / IMPACTER HANDLE
  • UNIVERSAL GLENOID INLAY EXTRACTOR
  • UNIVERSAL GLENOID METALBACK EXTRACTOR

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