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Instrument: 6mm Trial Parallel PEEK Small Single Joint Lesser Metatarsal
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
• Calcaneal Z Lengthening Osteotomies
• MTP Lengthening Arthrodesis
• Lesser Metatarsal-Cuneiform Lengthening Arthrodesis
• Navicular-Cuneiform Arthrodesis
• Talonavicular 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.
LM-1414T-0600
In Commercial Distribution
- 00810135962728 ()
- Orthopaedic inorganic implant inserter/extractor, reusable
Lesser Metatarsal Wedge Staple Drill Guide
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
• Calcaneal Z Lengthening Osteotomies
• MTP Lengthening Arthrodesis
• Lesser Metatarsal-Cuneiform Lengthening Arthrodesis
• Navicular-Cuneiform Arthrodesis
• Talonavicular 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-LMSDG
In Commercial Distribution
- 00810135962704 ()
- General internal orthopaedic fixation system implantation kit
Lesser Metatarsal Kwire Sleeve
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
• Calcaneal Z Lengthening Osteotomies
• MTP Lengthening Arthrodesis
• Lesser Metatarsal-Cuneiform Lengthening Arthrodesis
• Navicular-Cuneiform Arthrodesis
• Talonavicular 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-LMKSL
In Commercial Distribution
- 00810135962674 ()
- General internal orthopaedic fixation system implantation kit
Lesser Metatarsal Wedge Screw Targeting Guide
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
• Calcaneal Z Lengthening Osteotomies
• MTP Lengthening Arthrodesis
• Lesser Metatarsal-Cuneiform Lengthening Arthrodesis
• Navicular-Cuneiform Arthrodesis
• Talonavicular 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-LMSCG
In Commercial Distribution
- 00810135962667 ()
- General internal orthopaedic fixation system implantation kit
Lesser Metatarsal/Midfoot Wedge Inserter Shaft
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
• Calcaneal Z Lengthening Osteotomies
• MTP Lengthening Arthrodesis
• Lesser Metatarsal-Cuneiform Lengthening Arthrodesis
• Navicular-Cuneiform Arthrodesis
• Talonavicular 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-MSHFT
In Commercial Distribution
- 00810135962650 ()
- General internal orthopaedic fixation system implantation kit
Instrument: Drill and Screw Guide Holding Screw. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-1000T-SGHS
In Commercial Distribution
- 00810135961431 ()
- General internal orthopaedic fixation system implantation kit
EARP DISC RAKE ANGLED.
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DRA
In Commercial Distribution
- 00810135961059 ()
- Width: 35 Millimeter
- Depth: 22 Millimeter
- Height: 14 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP DISC RAKE
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DR
In Commercial Distribution
- 00810135961042 ()
- Width: 35 Millimeter
- Depth: 22 Millimeter
- Height: 14 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X12 12°
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-1212
In Commercial Distribution
- 00810135960892 ()
- Width: 35 Millimeter
- Depth: 22 Millimeter
- Height: 12 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X14 6°
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-0614
In Commercial Distribution
- 00810135960885 ()
- Width: 35 Millimeter
- Depth: 22 Millimeter
- Height: 14 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X12 6°
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-0612
In Commercial Distribution
- 00810135960878 ()
- Width: 35 Millimeter
- Depth: 22 Millimeter
- Height: 12 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X10 6°
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-0610
In Commercial Distribution
- 00810135960861 ()
- Width: 35 Millimeter
- Depth: 22 Millimeter
- Height: 10 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP, TRIAL 18X35X14 12°
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1835-1214
In Commercial Distribution
- 00810135960854 ()
- Width: 35 Millimeter
- Depth: 18 Millimeter
- Height: 14 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP, TRIAL 18X35X14 6°
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1835-0614
In Commercial Distribution
- 00810135960830 ()
- Width: 35 Millimeter
- Depth: 18 Millimeter
- Height: 14 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP, TRIAL 18X35X10 6°
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1835-0610
In Commercial Distribution
- 00810135960816 ()
- Width: 35 Millimeter
- Depth: 18 Millimeter
- Height: 10 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP, TRIAL 14X35X08 0°
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1435-0008
In Commercial Distribution
- 00810135960786 ()
- Height: 8 Millimeter
- Depth: 14 Millimeter
- Width: 35 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP, TRIAL 14X25X08 0°
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1425-0008
In Commercial Distribution
- 00810135960779 ()
- Height: 8 Millimeter
- Width: 25 Millimeter
- Depth: 14 Millimeter
- General internal orthopaedic fixation system implantation kit
EARP Retractor, EARP BLADE 150.
The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-R_001-150
In Commercial Distribution
- 00810135960748 ()
- Self-retaining surgical retractor, reusable
EARP Retractor, EARP BLADE 140.
The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-R_001-140
In Commercial Distribution
- 00810135960731 ()
- Self-retaining surgical retractor, reusable
EARP Retractor, EARP BLADE 130.
The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-R_001-130
In Commercial Distribution
- 00810135960724 ()
- Self-retaining surgical retractor, reusable