Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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DIST, RED 3, FOR HELMET, FRAME, 2 DIST SPINDLES
KLS-Martin L.P.
51-595-01-04
Not in Commercial Distribution

  • 00888118082893 ()

  • 7 HOLE, 39 MM BAR


  • Implantable craniofacial bone distractor
VERTICAL BAR, RED 2, W/GROOVE, CARBON
KLS-Martin L.P.
51-585-12-04
In Commercial Distribution

  • 00888118082886 ()

  • 120 MM


  • Implantable craniofacial bone distractor
SEGMENT, RED 2, ROUNDED FIXATION, RIGHT, PURPLE, ALUMINUM
KLS-Martin L.P.
51-583-02-04
In Commercial Distribution

  • 00888118082862 ()

  • 11 HOLE, 25 MM


  • Implantable craniofacial bone distractor
SEGMENT, RED 2, ROUNDED FIXATION, LEFT, PURPLE, ALUMINUM
KLS-Martin L.P.
51-583-01-04
In Commercial Distribution

  • 00888118082855 ()

  • 11 HOLE, 25 MM


  • Implantable craniofacial bone distractor
SPLINT, RED 2, TLTS, RETENTION, T LONG, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-582-62-09
In Commercial Distribution

  • 00888118082831 ()

  • 10 HOLE, T=1.5 MM


  • Implantable craniofacial bone distractor
SPLINT, RED 2, RETENTION, STURMAN, T LONG, 90*, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-582-60-09
In Commercial Distribution

  • 00888118082824 ()

  • 8 HOLE, T=1.5 MM


  • Implantable craniofacial bone distractor
SPLINT, RED 2, RETENTION, STURMAN, T LONG, 90*, 1.5-1.8 MM SCREW, STAINLESS STEEL / TITANIUM
KLS-Martin L.P.
51-582-58-09
In Commercial Distribution

  • 00888118082817 ()

  • 8 HOLE, T=1.5 MM


  • Implantable craniofacial bone distractor
SPLINT, RED 2, RETENTION, LEIPZIG, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-582-55-04
In Commercial Distribution

  • 00888118082800 ()

  • 11 HOLE, T=1.8 MM


  • Implantable craniofacial bone distractor
SPLINT, RED 2, RETENTION, T LONG, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-582-51-09
In Commercial Distribution

  • 00888118082794 ()

  • 10 HOLE, T=1.5 MM


  • Implantable craniofacial bone distractor
SPLINT, RED 2, RETENTION, LEIPZIG, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-582-50-04
In Commercial Distribution

  • 00888118082787 ()

  • 11 HOLE, T=1.5 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, MIDFACE FIXATION, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
51-581-21-09
In Commercial Distribution

  • 00888118082763 ()

  • 2.0 X 7 MM THD, TTL=21 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, MIDFACE FIXATION, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
51-581-15-09
In Commercial Distribution

  • 00888118082756 ()

  • 2.0 X 5 MM THD, TTL=15 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, MIDFACE FIXATION, HABAL, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
51-581-10-09
In Commercial Distribution

  • 00888118082749 ()

  • 2.0 X 7.5 MM THD, TTL=10.5 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, MIDFACE FIXATION, HABAL, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
51-581-08-09
In Commercial Distribution

  • 00888118082732 ()

  • 2.0 X 5 MM THD, TTL= 8 MM


  • Implantable craniofacial bone distractor
PLATE, RED 2, MIDFACE FIXATION, ORBITAL, PAPAY, CVD, 1.5-1.8 MM SCREW, CP TITANIUM
KLS-Martin L.P.
51-581-06-09
In Commercial Distribution

  • 00888118082725 ()

  • 7 HOLE


  • Implantable craniofacial bone distractor
PLATE, RED 2, MIDFACE FIXATION, FORREST, 1.5-1.8 MM SCREW, CP TITANIUM
KLS-Martin L.P.
51-581-04-09
In Commercial Distribution

  • 00888118082718 ()

  • 4.3 MM STEP, 5 HOLE


  • Implantable craniofacial bone distractor
PLATE, RED 2, MIDFACE FIXATION, STR, 1.5-1.8 MM SCREW, CP TITANIUM
KLS-Martin L.P.
51-581-02-09
In Commercial Distribution

  • 00888118082701 ()

  • 3 HOLE


  • Implantable craniofacial bone distractor
PATIENT SCREWDRIVER, HEX, RED 2, NO MM/TURN MARKING
KLS-Martin L.P.
51-580-87-07
In Commercial Distribution

  • 00888118082688 ()


  • Implantable craniofacial bone distractor expansion tool, home-use
PATIENT SCREWDRIVER, HEX, RED 2, 0.5 AND 0.75 MM/TURN
KLS-Martin L.P.
51-580-85-07
In Commercial Distribution

  • 00888118082671 ()


  • Implantable craniofacial bone distractor expansion tool, home-use
HORIZONTAL CROSS BAR ASSEMBLY, RED 2, COMPLETE, PURPLE, ALUMINUM / STAINLESS STEEL
KLS-Martin L.P.
51-580-45-04
In Commercial Distribution

  • 00888118082664 ()

  • 33 MM, 85 MM WIDE


  • Implantable craniofacial bone distractor
HOLDER, RED 2, FOR HORIZONTAL CROSS BAR, PURPLE, ALUMINUM
KLS-Martin L.P.
51-580-35-04
In Commercial Distribution

  • 00888118082657 ()


  • Implantable craniofacial bone distractor
UPPER PART, RED 2, FRONT DIST SLIDER, PURPLE, ALUMINUM
KLS-Martin L.P.
51-580-27-04
In Commercial Distribution

  • 00888118082640 ()

  • 30 MM


  • Implantable craniofacial bone distractor
SPINDLE, RED 2, STAINLESS STEEL / TITANIUM
KLS-Martin L.P.
51-580-26-04
In Commercial Distribution

  • 00888118082633 ()

  • 33 MM


  • Implantable craniofacial bone distractor
MESH, RED 2, ADJ, 3DX GEAR, 1.5-1.8 MM SCREW, STAINLESS STEEL / TITANIUM
KLS-Martin L.P.
51-580-14-09
In Commercial Distribution

  • 00888118082626 ()

  • 222 HOLE, 12 X 19 HOLES


  • Implantable craniofacial bone distractor
CONNECTOR, RED 2, RETENTION SPLINT TO SPINDLE, TI-6AL-4V
KLS-Martin L.P.
51-580-13-09
In Commercial Distribution

  • 00888118082619 ()


  • Implantable craniofacial bone distractor
SPINDLE, RED 2, SQUARE, ADJ, STAINLESS STEEL / TITANIUM
KLS-Martin L.P.
51-580-12-04
In Commercial Distribution

  • 00888118082602 ()

  • 33 MM


  • Implantable craniofacial bone distractor
HORIZONTAL CROSS BAR, RED 2, GEARED, PURPLE, ALUMINUM / STAINLESS STEEL
KLS-Martin L.P.
51-580-11-04
In Commercial Distribution

  • 00888118082596 ()

  • 95 MM, 30 MM THD


  • Implantable craniofacial bone distractor
UPPER PART, RED 2, VERTICAL ANGULATION, PURPLE, ALUMINUM
KLS-Martin L.P.
51-580-10-04
In Commercial Distribution

  • 00888118082589 ()


  • Implantable craniofacial bone distractor
UPPER PART, RED 2, MULTI DIRECTIONAL, PURPLE, ALUMINUM
KLS-Martin L.P.
51-580-09-04
In Commercial Distribution

  • 00888118082572 ()


  • Implantable craniofacial bone distractor
HALO EXTENDER, RED 2, PURPLE, ALUMINUM / TITANIUM
KLS-Martin L.P.
51-580-08-04
In Commercial Distribution

  • 00888118082565 ()

  • 2 HOLE


  • Implantable craniofacial bone distractor
VERTICAL BAR, RED 2, GEARED, SQUARE, PURPLE, ALUMINUM / STAINLESS STEEL
KLS-Martin L.P.
51-580-07-04
In Commercial Distribution

  • 00888118082558 ()

  • 133 MM, 120 MM THD


  • Implantable craniofacial bone distractor
UPPER PART, RED 2, FEARON, LATERAL SWIVEL, PURPLE, ALUMINUM
KLS-Martin L.P.
51-580-06-04
In Commercial Distribution

  • 00888118082541 ()


  • Implantable craniofacial bone distractor
UPPER PART, RED 2, PURPLE, ALUMINUM
KLS-Martin L.P.
51-580-05-04
In Commercial Distribution

  • 00888118082534 ()


  • Implantable craniofacial bone distractor
SEGMENT, RED 2, RIGHT, PURPLE, ALUMINUM
KLS-Martin L.P.
51-580-02-04
In Commercial Distribution

  • 00888118082527 ()

  • 9 HOLE, 25 MM


  • Implantable craniofacial bone distractor
SEGMENT, RED 2, LEFT, PURPLE, ALUMINUM
KLS-Martin L.P.
51-580-01-04
In Commercial Distribution

  • 00888118082510 ()

  • 9 HOLE, 25 MM


  • Implantable craniofacial bone distractor
HORIZONTAL CROSS BAR ASSEMBLY, RED 2, COMPLETE, GREEN
KLS-Martin L.P.
51-579-88-04
Not in Commercial Distribution

  • 00888118082503 ()

  • 85 MM


  • Implantable craniofacial bone distractor
HORIZONTAL CROSS BAR ASSEMBLY, RED 2, COMPLETE, BLACK, ALUMINUM / STAINLESS STEEL
KLS-Martin L.P.
51-579-08-04
In Commercial Distribution

  • 00888118082459 ()

  • 85 MM


  • Implantable craniofacial bone distractor
POSITIVE STOP, RED 2, FOR HALO FIXATION SCREWS, TI-6AL-4V
KLS-Martin L.P.
51-575-99-09
In Commercial Distribution

  • 00888118082435 ()


  • Implantable craniofacial bone distractor
LOCK NUT, RED 2, KNURLED, FOR HALO FIXATION SCREWS, TI-6AL-4V
KLS-Martin L.P.
51-575-94-09
In Commercial Distribution

  • 00888118082404 ()


  • Implantable craniofacial bone distractor
BLADE, SCREWDRIVER, RED, FOR 51-575-90-07
KLS-Martin L.P.
51-575-92-07
In Commercial Distribution

  • 00888118082398 ()

  • 2.0/4.0 MM HEX, 118 MM


  • Surgical screwdriver, reusable
HANDLE, SCREWDRIVER, FOR 51-575-90-07
KLS-Martin L.P.
51-575-91-07
In Commercial Distribution

  • 00888118082381 ()


  • Surgical screwdriver, reusable
SCREWDRIVER, HEX, RED 2, COMPLETE, ADJUSTMENT, BLACK
KLS-Martin L.P.
51-575-90-07
In Commercial Distribution

  • 00888118082374 ()


  • Surgical screwdriver, reusable
HORIZONTAL CROSS BAR, RED 2, TI-6AL-4V
KLS-Martin L.P.
51-575-31-09
In Commercial Distribution

  • 00888118082367 ()

  • 120 MM


  • Implantable craniofacial bone distractor
HORIZONTAL CROSS BAR, RED 2, TI-6AL-4V
KLS-Martin L.P.
51-575-30-09
In Commercial Distribution

  • 00888118082350 ()

  • 85 MM


  • Implantable craniofacial bone distractor
VERTICAL BAR, RED 2, W/GROOVE, TI-6AL-4V
KLS-Martin L.P.
51-575-20-09
In Commercial Distribution

  • 00888118082343 ()

  • 150 MM


  • Implantable craniofacial bone distractor
VERTICAL BAR, RED 2, W/GROOVE, CARBON
KLS-Martin L.P.
51-575-17-04
In Commercial Distribution

  • 00888118082336 ()

  • 180 MM


  • Implantable craniofacial bone distractor
VERTICAL BAR, RED 2, W/GROOVE, CARBON
KLS-Martin L.P.
51-575-16-04
In Commercial Distribution

  • 00888118082329 ()

  • 150 MM


  • Implantable craniofacial bone distractor
HORIZONTAL CROSS BAR, RED 2, HALO, CARBON
KLS-Martin L.P.
51-575-15-04
In Commercial Distribution

  • 00888118082312 ()

  • 120 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, TRIAL POSITIONING, SMOOTH, FOR HALO, BLUE, CP TITANIUM
KLS-Martin L.P.
51-575-14-09
In Commercial Distribution

  • 00888118082305 ()

  • 41 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, HALO FIXATION, SMOOTH, SILVER, CP TITANIUM
KLS-Martin L.P.
51-575-12-91
In Commercial Distribution

  • 00888118082299 ()

  • TTL=55 MM


  • Implantable craniofacial bone distractor
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