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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5.0mm Correction L-Bunion Plate. 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-PLT-05
In Commercial Distribution

  • 00810005665704 ()

  • Height: 5.0 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Plate 40mm long. 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-40-4
In Commercial Distribution

  • 00810005665698 ()

  • Length: 40 Millimeter


  • External orthopaedic fixation system, single-use
Plate 30mm long. 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-30-4
In Commercial Distribution

  • 00810005665681 ()

  • Length: 30 Millimeter


  • External orthopaedic fixation system, single-use
3.00mm dia 16mm long non-locking 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-30-16N
In Commercial Distribution

  • 00810005665674 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 16 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 14mm long non-locking 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-30-14N
In Commercial Distribution

  • 00810005665667 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 14 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 12mm long non-locking 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-30-12N
In Commercial Distribution

  • 00810005665650 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 12 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 10mm long non-locking 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-30-10N
In Commercial Distribution

  • 00810005665643 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 10 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 8mm long non-locking 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-30-08N
In Commercial Distribution

  • 00810005665636 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 8 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 6mm long non-locking 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-30-06N
In Commercial Distribution

  • 00810005665629 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 6 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 16mm long non-locking 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-24-16N
In Commercial Distribution

  • 00810005665612 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 16 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 14mm long non-locking 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-24-14N
In Commercial Distribution

  • 00810005665605 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 14 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 12mm long non-locking 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-24-12N
In Commercial Distribution

  • 00810005665599 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 12 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 10mm long non-locking 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-24-10N
In Commercial Distribution

  • 00810005665582 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 10 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 8mm long non-locking 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-24-08N
In Commercial Distribution

  • 00810005665575 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 8 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 6mm long non-locking 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-24-06N
In Commercial Distribution

  • 00810005665568 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 6 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 16mm long locking 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-30-16L
In Commercial Distribution

  • 00810005665551 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 16 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 14mm long locking 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-30-14L
In Commercial Distribution

  • 00810005665544 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 14 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 12mm long locking 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-30-12L
In Commercial Distribution

  • 00810005665537 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 12 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 10mm long locking 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-30-10L
In Commercial Distribution

  • 00810005665520 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 10 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 8mm long locking 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-30-08L
In Commercial Distribution

  • 00810005665421 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 8 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 6mm long locking 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-30-06L
In Commercial Distribution

  • 00810005665414 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 6 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 16mm long locking 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-24-16L
In Commercial Distribution

  • 00810005665407 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 16 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 14mm long locking 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-24-14L
In Commercial Distribution

  • 00810005665391 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 14 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 12mm long locking 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-24-12L
In Commercial Distribution

  • 00810005665384 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 12 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 10mm long locking 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-24-10L
In Commercial Distribution

  • 00810005665377 ()

  • Length: 10 Millimeter
  • Outer Diameter: 2.40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 8mm long locking 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-24-08L
In Commercial Distribution

  • 00810005665360 ()

  • Length: 8 Millimeter
  • Outer Diameter: 2.40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 6mm long locking 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-24-06L
In Commercial Distribution

  • 00810005665353 ()

  • Length: 6 Millimeter
  • Outer Diameter: 6 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Javelin Screw Caddy Body. 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-1000C-103
In Commercial Distribution

  • 00810005663977 ()


  • Surgical instrument/implant rack
Javelin Lid. 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-1000C-102
In Commercial Distribution

  • 00810005663960 ()


  • Surgical instrument/implant rack
Javelin Case. 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-1000C-101
In Commercial Distribution

  • 00810005663953 ()


  • Surgical instrument/implant rack
Instrument: Small Olive Pin. 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-1001T-SPIN
In Commercial Distribution

  • 00810005663861 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Depth Gauge tool. 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-1001T-DPG
In Commercial Distribution

  • 00810005663854 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Olive Pin. 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-OPIN
In Commercial Distribution

  • 00810005663847 ()


  • General internal orthopaedic fixation system implantation kit
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
Instrument: Drill Guide. 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-DGID
In Commercial Distribution

  • 00810005663823 ()


  • General internal orthopaedic fixation system implantation kit
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: 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: 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
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
Orthospec is based on shock wave therapy method and is intended to apply shock waves to the heel tissue of patients who have Proximal Plantar Fasciitis and who have failed previous conservative therapies.
MEDISPEC LTD.
OR-3-A999u
In Commercial Distribution

  • 07290016498417 ()


  • Spark-gap orthopaedic extracorporeal shock wave therapy system
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVMYO
In Commercial Distribution

  • 50197106823963 ()
  • 10197106823965 ()
SCV31HVMYO

  • Cardiothoracic surgical procedure kit, medicated, single-use
3.0mm Correction L-Bunion Plate. 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-PLT-03
In Commercial Distribution

  • 00810005669344 ()

  • Height: 3.0 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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