ApprovalTrail

Medical device licence · 65464 · Class 3

INTERNAL DISTRACTORS

Yes: licensed in Canada

Licence status Issued (active); first licensed August 16, 2004. It is in Health Canada’s list of active licences.
Licence number
65464
Licence holder
Kls Martin L.P.Jacksonville, FL, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
August 16, 2004
Devices covered
119

Devices on this licence

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

  • ARNAUD-MARCHAC CRANIAL MONOBLOCK DISTRACTOR
  • DIRECT DRIVE ACTIVATOR
  • DISTRACTION, INTERNAL, ACT ARM, RIGID, REMOTE DETACH, CONCEALED TIP, 23 MM, TI-6AL-4V
  • DISTRACTION, INTERNAL, ALIGNMENT ROD
  • DISTRACTION, INTERNAL, DIST, LEFORT 1 HYPERDRIVE, LEFT
  • DISTRACTION, INTERNAL, DIST, LEFORT 1 HYPERDRIVE, RIGHT
  • DISTRACTION, INTERNAL, DIST, LEFORT 1 ZURICH TELE, IMD, LEFT
  • DISTRACTION, INTERNAL, DIST, LEFORT 1, TSMD, L PLATE, LEFT
  • DISTRACTION, INTERNAL, DIST, LEFORT 1, TSMD, L PLATE, RIGHT
  • DISTRACTION, INTERNAL, DIST, MANDIBLE, HYPERDRIVE, RTCH
  • DISTRACTION, INTERNAL, DIST, ZURICH 2, MODULAR, END DRV, BODY ONLY, RTCH, SCREW
  • DISTRACTION, INTERNAL, PATIENT ACTIVATOR
  • DISTRACTION, INTERNAL, PLATE, MODULAR, CRANIAL, NON SLIDING, HOOKS, SCREW, HOLE
  • DISTRACTION, INTERNAL, PLATE, MODULAR, CRANIAL, NON SLIDING, SCREW, HOLE
  • DISTRACTION, INTERNAL, PLATE, MODULAR, CRANIAL, SLIDING, HOOKS, SCREW, HOLE
  • DISTRACTION, INTERNAL, PLATE, MODULAR, CRANIAL, SLIDING, SCREW, HOLE
  • DISTRACTION, INTERNAL, SCREW
  • DISTRACTION, INTERNAL, STERILE, ACT ARM, RIGID, CARDANIC, CLIPPABLE
  • DISTRACTION, INTERNAL, STERILE, ACT ARM, FLEXIBLE, SNAKE
  • DISTRACTION, INTERNAL, STERILE, ACT ARM, RIGID, REMOTE DETACH
  • DISTRACTION, INTERNAL, STERILE, DIST, ALVEOLAR, MICRO TRACK, END DRV, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, CRANIAL, MICRO ZURICH 2, ARNAUD, END DRV, TOP RTCH, SCREW, 8 HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, CRANIAL, MICRO ZURICH 2, ARNAUD, MID DRV, TOP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, CRANIAL, MICRO ZURICH 2, FORREST, END DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, CRANIAL, MICRO ZURICH 2, END DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, CRANIAL, ZURICH 2, END DRV, OPP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 1, ZURICH 2, ADJ MIDFACE, BODY, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 1, ZURICH 2, LEFT, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 3/MONO, BI LEVEL MIDFACE, ADJ, RIGHT, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 3/MONO, MATTHEWS-TESSIER, END DRV, TOP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 3/MONO, MESH MIDFACE, BODY ONLY, RTCH SCREW
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 3/MONO, BI LEVEL MIDFACE, ADJ, LEFT, RTCH, SCREW, 35 HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 3/MONO, KAWAMOTO, URATA, CVD, RTCH, SCREW, HOLE, 4 X 4 MESH
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, RAMUS TRANS, END DRV, TOP RTCH, SCREW, HOLE, PLATES
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, TLTS TRANS, STR, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, WILLIAMS, MID DRV, OPP, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, MICRO ZURICH 2, MID DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, RAPID PALATAL EXPANDER 2, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, ALVEOLAR, TRACK, COLOGNE, END DRV, AND SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, ALVEOLAR, TRACK PLUS, END DRV, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, MICRO ZURICH 2, MID DRV, SQUARE MESH, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, MICRO ZURICH 2, URATA, END DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, SYMPHYSIS, ZURICH 1, ROTTERDAM, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, MICRO ZURICH 2, MID DRV, OPP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, EXTENSION, CARDANIC, DOUBLE, FOR ACT ARM
  • DISTRACTION, INTERNAL, STERILE, EXTENSION, CARDANIC, FOR ACT ARM
  • DISTRACTION, INTERNAL, STERILE, EXTENSION, RIGID, FOR ACT ARM
  • DISTRACTION, INTERNAL, STERILE, MESH, MESH MIDFACE, 8 X 8 HOLES
  • DISTRACTION, INTERNAL, STERILE, PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, AP HOLES, BRG, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, HEX DRIVER, THD
  • DISTRACTION, INTERNAL, STERILE, SIZER
  • DISTRACTION, INTERNAL, STERILE, SIZER, HOLE
  • DISTRACTION, INTERNAL, STERILE, TROCAR TIP, FOR ACT ARM
  • DISTRACTION, INTERNAL, TROCAR TIP, FOR ACT ARM
  • DISTRACTION, INTERNAL, TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT
  • DISTRACTION, INTERNAL, STERILE, ACT ARM, DIRECT DRIVE
  • DISTRACTION, INTERNAL, STERILE, ACT ARM, RIGID, REMOTE DETACH, CONCEALED TIP
  • DISTRACTION, INTERNAL, STERILE, ACT ARM, FLEXIBLE, CARDANIC
  • DISTRACTION, INTERNAL, STERILE, ACT ARM, RIGID, CARDANIC
  • DISTRACTION, INTERNAL, STERILE, ACT ARM, FLEXIBLE, SNAKE, REMOTE DETACH
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, MICRO ZURICH 2, END DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, MICRO ZURICH 2, LYPKA, END DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, 3DX, WILLIAMS, RIGHT, TOP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, CLOVERLEAF, END DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, TLTS TRANS, HERFORD, LEFT, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, WILLIAMS, RIGHT ANGLE, RIGHT, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, ALVEOLAR, TRACK, END DRV, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, CLEFT, MICRO ZURICH 2, LIOU TRANS, RIGHT, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, CLEFT, MICRO ZURICH 2, LIOU TRANS, LEFT, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, CRANIAL, ZURICH 2, END DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 1, ZURICH TELE, RIGHT, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 1, ZURICH 2, RIGHT, RTCH,SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 1, ZURICH TELE, LEFT, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 1, ZURICH TELE, LEFT, POSTERIOR BAR, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 1, ZURICH TELE, RIGHT, POSTERIOR BAR, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 3/MONO, KAWAMOTO, URATA, CVD, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, LEFORT 3/MONO, MESH MIDFACE, END DRV, BODY ONLY, SCREW
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, 3DX, WILLIAMS, LEFT, TOP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, NYU, END DRV, TOP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, TLTS TRANS, HERFORD, RIGHT, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, WILLIAMS, END DRV, OPP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, WILLIAMS, RIGHT ANGLE, LEFT, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, WOOD, BIDIRECT, LEFT, RTCH, SCREW, HOLE, PLATES
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, WOOD, BIDIRECT, RIGHT, RTCH, SCREW, HOLE, PLATES
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, HYPERDRIVE, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, HYPERDRIVE MICRO, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, MICRO ZURICH 2, END DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, MICRO ZURICH 2, MID DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, END DRV, TOP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, WILLIAMS, END DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, ZURICH 2, WILLIAMS, MID DRV, RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, DIST, PALATAL, ROTTERDAM, NON SYNDROMIC
  • DISTRACTION, INTERNAL, STERILE, DIST, PALATAL, ROTTERDAM, SYNDROMIC
  • DISTRACTION, INTERNAL, STERILE, DIST, MANDIBLE, MICRO ZURICH 2, END DRV, OPP RTCH, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, EXTENSION, RIGID, FOR REMOTE DETACH ACT ARMS, EMERGENCY
  • DISTRACTION, INTERNAL, STERILE, PLATE, CONSOLIDATION, FOR RAMUS TRANSPORT DEVICE, SCREW, HOLE
  • DISTRACTION, INTERNAL, STERILE, PLATE, TLCK TRANS, HOLE FOR SCREW
  • DISTRACTION, INTERNAL, STERILE, TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS
  • EXTENSION FOR ACTIVATION ARM
  • FEARON MATTHEWS-TESSIER DISTRACTOR
  • FLEX ACTIVATION ARM ONLY, CARDANIC
  • KAWAMOTO MIDFACE DISTRACTOR
  • MATTHEWS-TESSIER INTERNAL DISTRACTOR WITH DETACHABLE ARM
  • MICRO TRACK DISTRACTOR
  • MICRO ZURICH DISTRACTION DEVICE
  • MIDFACE DISTRACTOR WITH DETACHABLE ARM
  • PALATAL DISTRACTOR
  • RIGID ACTIVATION ARM ONLY, CARDANIC
  • THREADLOCK TRANSPORT DISTRACTOR
  • TRACK DISTRACTOR
  • TRACK PLUS DISTRACTOR
  • WILLIAMS ZURICH MANDIBULAR DEVICE, BODY ONLY
  • WOOD ZURICH INTRAORAL DISTRACTOR
  • ZURICH DISTRACTOR, BODY ONLY
  • ZURICH DISTRACTOR, CLOVERLEAF PLATE, END-DRIVEN
  • ZURICH DISTRACTOR, CLOVERLEAF, WITH 4 PLATES, BODY ONLY
  • ZURICH DISTRACTOR, MOSES/STUCKISTYLE
  • ZURICH MAXILLARY DISTRACTOR PLATES
  • ZURICH MAXILLARY DISTRACTOR PLATES W/DETACHABLE ARM

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