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: 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
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
Instrument: 30mm Targeting Jig Drill Guide. 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-JG30
In Commercial Distribution

  • 00810005662598 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Drill for 3.0mm Screw. 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-DR30
In Commercial Distribution

  • 00810005662581 ()


  • General internal orthopaedic fixation system implantation kit
BUNION PACK
Cardinal Health 200, LLC
SOP13BUJB5
In Commercial Distribution

  • 50195594598110 ()
  • 10195594598112 ()
SOP13BUJB5

  • Orthopaedic surgical procedure kit, non-medicated, single-use
BUNION PACK
Cardinal Health 200, LLC
SBACGBNNS6
In Commercial Distribution

  • 50195594638175 ()
  • 10195594638177 ()
SBACGBNNS6

  • Orthopaedic surgical procedure kit, medicated
NEUROLOGY INSTITUTE PACK
Cardinal Health 200, LLC
SNE29NEAK9
In Commercial Distribution

  • 50195594636430 ()
  • 10195594636432 ()
SNE29NEAK9

  • Neurosurgical procedure kit, non-medicated, single-use
BUNION PACK
Cardinal Health 200, LLC
SOPCGBNTF5
In Commercial Distribution

  • 50195594623980 ()
  • 10195594623982 ()
SOPCGBNTF5

  • Orthopaedic surgical procedure kit, medicated
BUNION PACK
Cardinal Health 200, LLC
SOPCGBNTF6
In Commercial Distribution

  • 50195594803771 ()
  • 10195594803773 ()
SOPCGBNTF6

  • Orthopaedic surgical procedure kit, medicated
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