ApprovalTrail

Medical device licence · 62301 · Class 3

UNIVERSAL CMF FIXATION SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed April 23, 2003. It is in Health Canada’s list of active licences.
Licence number
62301
Licence holder
Stryker Leibinger Gmbh & Co. KgKalamazoo, MI, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
April 23, 2003
Devices covered
135

Devices on this licence

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

  • 2.0MP LEFORT L PLATE
  • 3-D PLATE, CURVED, SQUARE SEGMENT
  • 3-D PLATE, MP, SQUARE
  • 3-D PLATE, RECTANGLE
  • 3-D PLATE,CURVED
  • AXS BLADE
  • AXS SCREWDRIVER BLADE
  • BASIC ORBITAL FLOOR PLATE
  • BICONCAVE WASHERS
  • BLADE F. 6514-7-200
  • BLADE F. 90DEG SCREWDRIVER
  • BONE PLATE, MP, 6 HOLE, CURVED BAR
  • BONE PLATE, MP, BAR
  • BONE PLATE, MP, CURVED
  • BONE PLATE, MP, PRE-BENT
  • BONE PLATE, MP, STRAIGHT
  • BONE PLATE, MP, STRAIGHT, BAR
  • BONE PLATE, MP, STRAIGHT, W/O BAR
  • BONE PLATE, MP, WITH BAR
  • BONE PLATE, RECTANGLE
  • BONE SCREWS, AXS, SELF-DRILLING UNIVERSAL 2.0 MP
  • BONE SCREWS, AXS, SELF-TAPPING UNIVERSAL 2.0 MP
  • BONE SCREWS, AXS, SELF-TAPPING UNIVERSAL MANDIBLE
  • BONE SCREWS, CROSS-PIN
  • BONE SCREWS, CROSS-PIN, MP, SELF-DRILLING
  • BONE SCREWS, EMERG, AXS, SELF-TAPPING UNIVERSAL 2.0 MP
  • BONE SCREWS, EMERG, AXS, SELF-TAPPING UNIVERSAL MANDIBLE
  • BONE SCREWS, EMERGENCY, CROSS-PIN
  • BONE SCREWS, EMERGENCY, MP, CROSS-PIN
  • BONE SCREWS, EMERGENCY, MP, SQUARE-FIT
  • BONE SCREWS, EMERGENCY, SQUARE-FIT, S-T
  • BONE SCREWS, MP, CROSS-PIN
  • BONE SCREWS, MP, SQUARE-FIT
  • BONE SCREWS, SQUARE-FIT, SELF-TAPPING
  • BONES SCREWS, AXS, SELF-DRILLING UNIVERSAL MANDIBLE
  • COMPLEX ORBITAL FLOOR PLATE
  • COMPRESSION PLATE
  • COMPRESSION PLATE, FOR SCREWS
  • DEPTH MEASURING GAUGE, MANDIBLE
  • DOUBLE 7-PLATE 4 HOLES
  • DOUBLE Y-PLATE
  • DOUBLE Y-PLATE, MP
  • DRILL GUIDE
  • FRACTURE PLATE
  • FRACTURE PLATE WITH BAR
  • FRACTURE PLATE, ANGLED
  • FRACTURE PLATE, C-SHAPE
  • FRACTURE PLATE, CURVED, WITH BAR
  • FRACTURE PLATE, PROFILE HEIGHT
  • FRACTURE PLATE, STRAIGHT
  • ISOLATED ORBITAL FLOOR PLATE
  • L-PLATE MP OBLIQUE LEFT
  • L-PLATE MP OBLIQUE RIGHT
  • L-PLATE, 100 DEGREE, STANDARD
  • L-PLATE, 100 DEGREE, UPPER-FACE
  • L-PLATE, 115 DEGREE
  • L-PLATE, 90 DEGREE, STANDARD
  • L-PLATE, BAR
  • L-PLATE, BAR, STANDARD
  • L-PLATE, MP
  • L-PLATE, MP, BAR
  • L-PLATE, MP, MID-FACE, BAR, MALL.
  • L-PLATE, STANDARD, 90 DEGREE
  • LAG SCREWS, CROSS-PIN
  • LOCKING SCREWS, AXS, SELF-DRILLING UNIVERSAL MANDIBLE
  • LOCKING SCREWS, AXS, SELF-TAPPING UNIVERSAL MANDIBLE
  • LOCKING SCREWS, CROSS-PIN
  • LOCKING SCREWS, EMERG, AXS, SELF-TAPPING UNIVERSAL MANDIBLE
  • LOCKING SCREWS, EMERGENCY, CROSS-PIN
  • MAND. RECON PLATE, STRAIGHT, WITH TEMPLATE
  • MANDIBLE RECONPLATE, HEMI
  • MANDIBULAR RECONSTRUCT. PLATE, WITH TEMPLATE
  • MEASURING SLEEVE
  • MINI PLATE
  • MINI PLATE, CURVED WITH BAR
  • MINI PLATE, PRE-BENT, WITH BAR
  • MINI PLATE, PROFILE HEIGHT
  • MINI PLATE, PROFILE HEIGHT WITH BAR
  • MINI PLATE, STRAIGHT, PROFILE HEIGHT
  • MINI PLATE, STRAIGHT, WITH BAR
  • MINI PLATE, WITH BAR
  • MINI PLATE, WITH TAB
  • MP PLATE
  • MP PLATE, CURVED
  • MP PLATE, CURVED, BAR
  • MP PLATE, DBLE STRIP, MALL, MIDEFACE
  • MP PLATE, REINFORCED BAR
  • MP PLATE, STRAIGHT, MALL.
  • MP Z-PLATE, LEFT
  • MP Z-PLATE, RIGHT
  • PLATE, L-Y, PRE-BENT
  • PLATE, MP, SAGITTAL SPLIT, SHORT
  • PLATE, MP, WITH TAB, LEFT
  • PLATE, MP, WITH TAB, RIGHT
  • PLATE, STRAIGHT, DOUBLE STRIP, MP
  • PRIMARY FULL MAND PLATE, WITH TEMPLATE
  • PRIMARY HEMI MAND PLATE, WITH TEMPLATE
  • PRIMARY MAND RECON PLATE, WITH TEMPLATE
  • PRIMARY RECONSTRUCTION PLATE
  • RECON FULL MAND PLATE, WITH TEMPLATE
  • RECON HEMI MAND PLATE WITH TEMPLATE
  • SCREWDRIVER BLADE
  • T-PLATE
  • T-PLATE, MP
  • TEMPORARY RECON SCREW HOLDER
  • TRAPEZE PLATE, MP
  • TROCAR
  • UNIVERSAL CMF FIXATION SYSTEM - 1.2MM UPPER-FACE SCREWS
  • UNIVERSAL CMF FIXATION SYSTEM - 1.4MM EMERGENCY SCREW - UPPER-FACE
  • UNIVERSAL CMF FIXATION SYSTEM - 1.7MM MID-FACE LOCKING SCREWS
  • UNIVERSAL CMF FIXATION SYSTEM - 1.7MM MID-FACE SCREWS
  • UNIVERSAL CMF FIXATION SYSTEM - 1.9MM EMERGENCY SCREW - MID-FACE
  • UNIVERSAL CMF FIXATION SYSTEM - 2-HOLE PLATE
  • UNIVERSAL CMF FIXATION SYSTEM - 2X34 HOLE STRAIGHT PLATE - MID-FACE
  • UNIVERSAL CMF FIXATION SYSTEM - GSP MID-FACE
  • UNIVERSAL CMF FIXATION SYSTEM - LOCKING GPS
  • UNIVERSAL CMF FIXATION SYSTEM - LOCKING SCREW PLATES
  • UNIVERSAL CMF FIXATION SYSTEM - LOCKING SLIDING SAGITAL SPLIT PLATE
  • UNIVERSAL CMF FIXATION SYSTEM - MALLEABLE UPPER-FACE PLATES
  • UNIVERSAL CMF FIXATION SYSTEM - MALLEABLE UPPER-FACE/MID-FACE PLATES
  • UNIVERSAL CMF FIXATION SYSTEM - MANDIBLE PLATES - MINI PLATES
  • UNIVERSAL CMF FIXATION SYSTEM - MID-FACE PRE BENT LE FORT 1 PLATES
  • UNIVERSAL CMF FIXATION SYSTEM - MID-FACE STANDARD PLATES
  • UNIVERSAL CMF FIXATION SYSTEM - PRE BENT CHIN PLATE
  • UNIVERSAL CMF FIXATION SYSTEM - SAGITAL SPLIT PLATE
  • UNIVERSAL CMF FIXATION SYSTEM - UPPER-FACE STANDARD PLATES
  • UNIVERSAL FIXATION DRILL FOR 20MM SCREWS, STRYKER-SHAFT
  • UNIVERSAL MANDIBLE DEPTH GAUGE
  • UNIVERSAL MID-FACE BONE SCREWS
  • UNIVERSAL MID-FACE BONE SCREWS, EMERG
  • UNIVERSAL MID-FACE LOCKING SCREWS
  • UNIVERSAL UPPER-FACE BONE SCREWS
  • UNIVERSAL UPPER-FACE BONE SCREWS, EMERG
  • Y-PLATE MP
  • Y-PLATE, MP

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