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: 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
Instrument: 40mm 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-JG40
In Commercial Distribution

  • 00810005662604 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Drill for 2.4mm 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-DR24
In Commercial Distribution

  • 00810005662574 ()


  • General internal orthopaedic fixation system implantation kit
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
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
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
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
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
Tray: MIS Bunion K-Wire Tube. 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-1000C-105
In Commercial Distribution

  • 00810005667852 ()


  • Surgical instrument/implant rack
Tray: MIS Bunion Caddy Lid. 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-1000C-104
In Commercial Distribution

  • 00810005667845 ()


  • Surgical instrument/implant rack
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