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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, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TL-1135T-714
In Commercial Distribution

  • 00814008022199 ()

  • Angle: 7 degree
  • Length: 11 Millimeter
  • Width: 35 Millimeter
  • Height: 14 Millimeter


  • Surgical tamp, reusable
Loading Funnel
Stryker Corporation
48288211
In Commercial Distribution

  • 07613327175776 ()
48288211

  • Orthopaedic cement preparation/delivery kit
Loading Tool
Stryker Corporation
48288212
In Commercial Distribution

  • 07613327175752 ()
48288212

  • Orthopaedic cement preparation/delivery kit
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
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
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
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
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
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
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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