ApprovalTrail

Medical device licence · 103193 · Class 3

MONSTER SCREW SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed July 12, 2019. It is in Health Canada’s list of active licences.
Licence number
103193
Licence holder
Paragon 28, Inc.Englewood, CO, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
July 12, 2019
Devices covered
70

Devices on this licence

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

  • CANNULATED DRILL
  • MONSTER SYSTEM, DRILL CANNULATED, 3/16" SQ. CONNECTION
  • MONSTER SYSTEM, DRILL CANNULATED, AO
  • MONSTER SYSTEM, DRILL LONG, CANNULATED 3/16 SQ., SS
  • MONSTER SYSTEM, DRILL SOLID, MEASURING, AO
  • MONSTER SYSTEM, DRILL SOLID, MEASURING, LONG, AO
  • MONSTER SYSTEM, DRILL SOLID, TROCAR TIP, AO
  • MONSTER SYSTEM, DRIVER, CANNULATED, HEXALOBE
  • MONSTER SYSTEM, FULL OLIVE WIRE, THREADED
  • MONSTER SYSTEM, JACOBS ADAPTER
  • MONSTER SYSTEM, K-WIRE, DOUBLE-ENDED TROCAR TIP
  • MONSTER SYSTEM, K-WIRE, DOUBLE-ENDED TROCAR TIP, SMOOTH
  • MONSTER SYSTEM, K-WIRE, SINGLE ENDED TROCAR TIP, SMOOTH
  • MONSTER SYSTEM, K-WIRE, SINGLE ENDED TROCAR TIP, THREADED
  • MONSTER SYSTEM, K-WIRE, SINGLE TROCAR TIP, SMOOTH, W/ FLUOROBAND
  • MONSTER SYSTEM, LAPIDUS NAIL, TARGETING GUIDE OLIVE WIRE,THREADED
  • MONSTER SYSTEM, MINI-MONSTER SCREW FULL THREAD, BLUNT TIP, TIA
  • MONSTER SYSTEM, MINI-MONSTER SCREW FULL THREAD, TIA
  • MONSTER SYSTEM, MINI-MONSTER SCREW HEADLESS, LONG THREAD, TIA
  • MONSTER SYSTEM, MINI-MONSTER SCREW HEADLESS, SHORT THREAD, TIA
  • MONSTER SYSTEM, MINI-MONSTER SCREW LONG THREAD, BLUNT TIP, TIA
  • MONSTER SYSTEM, MINI-MONSTER SCREW LONG THREAD, TIA
  • MONSTER SYSTEM, MINI-MONSTER SCREW SHORT THREAD, BLUNT TIP, TIA
  • MONSTER SYSTEM, MINI-MONSTER SCREW SHORT THREAD, TIA
  • MONSTER SYSTEM, MINI-MONSTER, WASHER DEEP WELL, TIA
  • MONSTER SYSTEM, MONSTER BEAM, HEADLESS, FULL THREAD
  • MONSTER SYSTEM, MONSTER BEAM, HEADLESS, FULL THREAD
  • MONSTER SYSTEM, MONSTER BEAM, HEADLESS, SHORT THREAD
  • MONSTER SYSTEM, MONSTER BEAM, SOLID, HEADLESS, SHORT THREAD
  • MONSTER SYSTEM, MONSTER BITE SCREW SHORT THREAD
  • MONSTER SYSTEM, MONSTER BITE SCREW, LONG THREAD
  • MONSTER SYSTEM, MONSTER SCREW BOWL WASHER
  • MONSTER SYSTEM, MONSTER SCREW FULL THREAD, TIA
  • MONSTER SYSTEM, MONSTER SCREW HEADLESS, FULL THREAD, SHARP TIP, TIA
  • MONSTER SYSTEM, MONSTER SCREW HEADLESS, LONG THREAD, TIA
  • MONSTER SYSTEM, MONSTER SCREW HEADLESS, MED THREAD, TIA
  • MONSTER SYSTEM, MONSTER SCREW HEADLESS, MEDIUM THREAD, SHARP TIP, TIA
  • MONSTER SYSTEM, MONSTER SCREW HEADLESS, SHORT THREAD, TIA
  • MONSTER SYSTEM, MONSTER SCREW LONG THREAD, TIA
  • MONSTER SYSTEM, MONSTER SCREW MED THREAD, TIA
  • MONSTER SYSTEM, MONSTER SCREW SHORT THREAD, BLUNT TIP, TIA
  • MONSTER SYSTEM, MONSTER SCREW SHORT THREAD, TIA
  • MONSTER SYSTEM, MONSTER SCREW, LONG THREAD, BLUNT TIP SCREW
  • MONSTER SYSTEM, MONSTER SCREW, MED THREAD, BLUNT TIP SCREW
  • MONSTER SYSTEM, MONSTER SCREW, SHORT THREAD, BLUNT TIP SCREW
  • MONSTER SYSTEM, MONSTER WASHER TIA
  • MONSTER SYSTEM, NITINOL K-WIRE, SMOOTH
  • MONSTER SYSTEM, NITINOL ORIENTATION PIN, SINGLE ENDED TROCAR TIP, SMOOTH
  • MONSTER SYSTEM, OLIVE WIRE, SMOOTH
  • MONSTER SYSTEM, OLIVE WIRE, THREADED
  • MONSTER SYSTEM, OVER DRILL CANNULATED 3/16 SQ. CONNECTION
  • MONSTER SYSTEM, OVER DRILL CANNULATED, AO
  • MONSTER SYSTEM, OVER DRILL SOLID, AO
  • MONSTER SYSTEM, OVER DRILL SOLID, TROCAR TIP, AO
  • MONSTER SYSTEM, P28, DRILL CANNULATED 3/16 SQ. SS
  • MONSTER SYSTEM, P28, DRILL CANNULATED SS
  • MONSTER SYSTEM, P28, DRIVER CANNULATED, SS
  • MONSTER SYSTEM, P28, DRIVER, LONG, CANNULATED, SS
  • MONSTER SYSTEM, P28, K-WIRE, SINGLE TROCAR, SMOOTH, SS
  • MONSTER SYSTEM, P28, K-WIRE, SINGLE TROCAR, THREADED, SS
  • MONSTER SYSTEM, SCREW DRIVER ATTACHMENT, CANNULATED, AO
  • MONSTER SYSTEM, SCREW DRIVER ATTACHMENT, CANNULATED, MODIFIED
  • MONSTER SYSTEM, SCREW DRIVER ATTACHMENT, SOLID, AO
  • MONSTER SYSTEM, SCREW DRIVER ATTACHMENT, SOLID, AO
  • MONSTER SYSTEM, SCREW DRIVER ATTACHMENT, TUFFNEK, SOLID, AO
  • MONSTER SYSTEM, SLOTTED BOWL WASHER
  • PRECISION MIS SCREW, CANNULATED
  • REDUCTION WIRE
  • SLOTTED BOWL WASHER
  • SMOOTH K-WIRE

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