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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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Javelin - 00810005662611

Instrument: Targeting Jig Plate Inserter. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-1000T-JGIN
In Commercial Distribution

  • 00810005662611 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Healix - 00810005662567

Kwire Trocar 0.8mm X 150mm. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CSRW-1000T-311
In Commercial Distribution

  • 00810005662567 ()


  • Orthopaedic bone wire

FOCUS - 00810005662550

Pedicle screw cross connect holder Class 1 instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-113
In Commercial Distribution

  • 00810005662550 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005662482

Handle, Medium. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CSRW-1000T-501
In Commercial Distribution

  • 00810005662482 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005662475

Handle, Small. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CSRW-1000T-500
In Commercial Distribution

  • 00810005662475 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005662444

Kwire Trocar 1.0mm X 150mm. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CSRW-1000T-320
In Commercial Distribution

  • 00810005662444 ()


  • Orthopaedic bone wire

Healix - 00810005662314

Kwire Trocar 0.7mm X 150mm. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CSRW-1000T-310
In Commercial Distribution

  • 00810005662314 ()


  • Orthopaedic bone wire

Vertex - 00810005661003

Instrument: Staple Distractor. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
STK-1000T-DIS1
In Commercial Distribution

  • 00810005661003 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Javelin - 00810005660914

Instrument: AO Handle, Small. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAN-1000T-AOSM
In Commercial Distribution

  • 00810005660914 ()


  • General internal orthopaedic fixation system implantation kit

Javelin - 00810005660907

Instrument: Broach Extractor. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-1000T-BRX
In Commercial Distribution

  • 00810005660907 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Javelin - 00810005660891

Instrument: Plate Extractor. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-1000T-PLX
In Commercial Distribution

  • 00810005660891 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Javelin - 00810005660884

Instrument: Slotted Mallet. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-1000T-MLT
In Commercial Distribution

  • 00810005660884 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005669429

Instrument: CC Wedge 14mm 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-2514T-CC
In Commercial Distribution

  • 00810005669429 ()

  • 14mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669412

Instrument: CC Wedge 12mm 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-2512T-CC
In Commercial Distribution

  • 00810005669412 ()

  • 12mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669405

Instrument: CC Wedge 10mm 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-2510T-CC
In Commercial Distribution

  • 00810005669405 ()

  • 10mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669399

Instrument: CC Wedge 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-CC
In Commercial Distribution

  • 00810005669399 ()

  • 8mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669382

Instrument: Trigon CC Wedge 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-CGPB
In Commercial Distribution

  • 00810005669382 ()


  • Surgical tissue compression device

Radian MIS Bunion System - 00810005669238

Instrument: K-Wire Depth Gauge. 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-KDG
In Commercial Distribution

  • 00810005669238 ()


  • General internal orthopaedic fixation system implantation kit

Vector - 00810005668972

Inserter for implants 3.0mm diameter instrument. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-1001T-IS30
In Commercial Distribution

  • 00810005668972 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005668736

Instrument: Large Cotton 8mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-182008T-CO
In Commercial Distribution

  • 00810005668736 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668712

Instrument: Large Cotton 6mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-182006T-CO
In Commercial Distribution

  • 00810005668712 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668705

Instrument: Small Cotton 8mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-161608T-CO
In Commercial Distribution

  • 00810005668705 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668699

Instrument: Small Cotton 7mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-161607T-CO
In Commercial Distribution

  • 00810005668699 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668682

Instrument: Small Cotton 6mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-161606T-CO
In Commercial Distribution

  • 00810005668682 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668675

Instrument: Large Evans 12mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-202212T-EV
In Commercial Distribution

  • 00810005668675 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668668

Instrument: Large Evans 10mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-202210T-EV
In Commercial Distribution

  • 00810005668668 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668651

Instrument: Large Evans 8mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-202208T-EV
In Commercial Distribution

  • 00810005668651 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668644

Instrument: Large Evans 6mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-202206T-EV
In Commercial Distribution

  • 00810005668644 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668637

Instrument: Medium Evans 12mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-182012T-EV
In Commercial Distribution

  • 00810005668637 ()


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005668620

Instrument: Medium Evans 10mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-182010T-EV
In Commercial Distribution

  • 00810005668620 ()


  • General internal orthopaedic fixation system implantation kit
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