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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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Radian MIS Bunion System - 00810005663830

Instrument: 3.0mm Diameter Drill. 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-DR30
In Commercial Distribution

  • 00810005663830 ()


  • General internal orthopaedic fixation system implantation kit

Javelin - 00810005662864

Instrument: Screw 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-ISRT
In Commercial Distribution

  • 00810005662864 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Healix - 00810005662833

T6 Multi-Drive Inserter. 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-021
In Commercial Distribution

  • 00810005662833 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Healix - 00810005662703

Kwire Trocar 1.3mm 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-330
In Commercial Distribution

  • 00810005662703 ()


  • Orthopaedic bone wire

Healix - 00810005662673

Pick-Ups. 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-800
In Commercial Distribution

  • 00810005662673 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005662666

AO Power Adaptor. 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-700
In Commercial Distribution

  • 00810005662666 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005662659

Drill Guide Sleeve 4.5. 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-285
In Commercial Distribution

  • 00810005662659 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005662642

Handle, Large. 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-502
In Commercial Distribution

  • 00810005662642 ()


  • General internal orthopaedic fixation system implantation kit

Javelin - 00810005662635

Instrument: Depth Gauge. 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-1001T-DPG
In Commercial Distribution

  • 00810005662635 ()


  • General internal orthopaedic fixation system implantation kit

Javelin - 00810005662628

Instrument: Broach. 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-BRCH
In Commercial Distribution

  • 00810005662628 ()


  • General internal orthopaedic fixation system implantation kit
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