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

  • 00810009465973 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
Curette
MIZUHO AMERICA, INC.
10020MA
In Commercial Distribution

  • 00810009465805 ()


  • Bone curette, reusable
Curette
MIZUHO AMERICA, INC.
10019MA
In Commercial Distribution

  • 00810009465799 ()


  • Bone curette, reusable
Curette
MIZUHO AMERICA, INC.
10018MA
In Commercial Distribution

  • 00810009465782 ()


  • Bone curette, reusable
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