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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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Trigon - 00810005669955

Instrument: Subtalar 8mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2508T-ST
In Commercial Distribution

  • 00810005669955 ()

  • 8mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669948

Instrument: Subtalar 6mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2506T-ST
In Commercial Distribution

  • 00810005669948 ()

  • 6mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669931

Instrument: Trigon Subtalar Graft Packing Block. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1000T-SGPB
In Commercial Distribution

  • 00810005669931 ()


  • Surgical tissue compression device

Trigon - 00810005669924

Instrument: Subtalar Calc Targeting Jig Angle. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001T-CJA
In Commercial Distribution

  • 00810005669924 ()


  • Surgical drill guide, reusable

Trigon - 00810005669917

Instrument: Subtalar Calc Targeting Jig Straight. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001T-CJS
In Commercial Distribution

  • 00810005669917 ()


  • Surgical drill guide, reusable

Trigon - 00810005669900

Instrument: Subtalar Wedge Inserter. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001T-STI
In Commercial Distribution

  • 00810005669900 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Teardrop Probe, 2.5mm Tip, 90 Degrees Up, Bayonet, 15cm WL - 00810009465973

Probe
MIZUHO AMERICA, INC.
07-820-27XL
In Commercial Distribution

  • 00810009465973 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable

Cup Curette, 1.5x2mm, 100 Degrees Reverse Angle, 10cm WL - 00810009465805

Curette
MIZUHO AMERICA, INC.
10020MA
In Commercial Distribution

  • 00810009465805 ()


  • Bone curette, reusable

Cup Curette, 2x2.5mm, 100 Degrees Reverse Angle, 10cm WL - 00810009465799

Curette
MIZUHO AMERICA, INC.
10019MA
In Commercial Distribution

  • 00810009465799 ()


  • Bone curette, reusable

Cup Curette, 1.5x2mm, 90 Degrees Up, 10cm WL - 00810009465782

Curette
MIZUHO AMERICA, INC.
10018MA
In Commercial Distribution

  • 00810009465782 ()


  • Bone curette, reusable
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