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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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8mm (0° Sagittal 8° Transverse) Lapidus Wedge . The Trigon HA Stand-Alone Wedge Fixagtion 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 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.
LD-080008T-28
In Commercial Distribution

  • 00810005669733 ()

  • Height: 8 Millimeter


  • General internal orthopaedic fixation system implantation kit
8mm (0° Sagittal 4° Transverse) Lapidus Wedge . The Trigon HA Stand-Alone Wedge Fixagtion 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 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.
LD-080004T-28
In Commercial Distribution

  • 00810005669719 ()

  • Height: 8 Millimeter


  • General internal orthopaedic fixation system implantation kit
5mm (4° Sagittal 6° Transverse) Lapidus Wedge . 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 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.
LD-050406T-28
In Commercial Distribution

  • 00810005669696 ()

  • Height: 5 Millimeter


  • General internal orthopaedic fixation system implantation kit
5mm (4° Sagittal 4° Transverse) Lapidus Wedge . 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 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.
LD-050404T-28
In Commercial Distribution

  • 00810005669689 ()

  • Height: 5 Millimeter


  • General internal orthopaedic fixation system implantation kit
5mm (2° Sagittal 6° Transverse) Lapidus Wedge . 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 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.
LD-050206T-28
In Commercial Distribution

  • 00810005669665 ()

  • Height: 5 Millimeter


  • General internal orthopaedic fixation system implantation kit
5mm (2° Sagittal 4° Transverse) Lapidus Wedge . 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 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.
LD-050204T-28
In Commercial Distribution

  • 00810005669658 ()

  • Height: 5 Millimeter


  • General internal orthopaedic fixation system implantation kit
5mm (0° Sagittal 8° Transverse) Lapidus Wedge . 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 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.
LD-050008T-28
In Commercial Distribution

  • 00810005668019 ()

  • Height: 5 Millimeter


  • General internal orthopaedic fixation system implantation kit
5mm (0° Sagittal 6° Transverse) Lapidus Wedge . 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 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.
LD-050006T-24
In Commercial Distribution

  • 00810005667654 ()

  • Height: 5 Millimeter


  • General internal orthopaedic fixation system implantation kit
5mm Trial (0° Sagittal 4° Transverse) Lapidus Wedge . 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 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.
LD-050004T-24
In Commercial Distribution

  • 00810005667647 ()

  • Height: 5 Millimeter


  • General internal orthopaedic fixation system implantation kit
8mm (2° Sagittal 6° Transverse) Lapidus Wedge . The Trigon HA Stand-Alone Wedge Fixagtion 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 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.
LD-080206T-24
In Commercial Distribution

  • 00810005667593 ()

  • Height: 8 Millimeter


  • General internal orthopaedic fixation system implantation kit
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