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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Dual Radius Humeral Head
Howmedica Osteonics Corp.
R5350-4521
In Commercial Distribution

  • 07613327139457 ()

  • Thickness: 21.0 Millimeter
  • Diameter: 45.0 Millimeter
R5350-4521

  • Total shoulder prosthesis
Humeral Component
Howmedica Osteonics Corp.
R5351-4514
In Commercial Distribution

  • 07613327139440 ()

  • Distal Diameter: 14.0 Millimeter
R5351-4514

  • Coated shoulder humeral stem prosthesis
Dual Radius Humeral Head
Howmedica Osteonics Corp.
R5350-4512
In Commercial Distribution

  • 07613327139433 ()

  • Thickness: 12.0 Millimeter
  • Diameter: 45.0 Millimeter
R5350-4512

  • Total shoulder prosthesis
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
Bunion Correction Implants
Treace Medical Concepts, Inc.
SK57
In Commercial Distribution

  • 00810111222464 ()


  • Orthopaedic fixation plate, non-bioabsorbable
  • Orthopaedic bone screw (non-sliding)
Screw, Ø4.5 x 12mm, Self-Tapping Dark Blue, Fixed
Ulrich Medical Usa, Inc.
UU201-42-4512
In Commercial Distribution

  • 00810076337319 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Ø4.0 x 24mm, Self-Drilling/Self-Tapping Bronze, Fixed
Ulrich Medical Usa, Inc.
UU201-42-4024
In Commercial Distribution

  • 00810076337302 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Ø4.0 x 22mm, Self-Drilling/Self-Tapping Teal, Fixed
Ulrich Medical Usa, Inc.
UU201-42-4022
In Commercial Distribution

  • 00810076337296 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Ø4.0 x 20mm, Self-Drilling/Self-Tapping Green, Fixed
Ulrich Medical Usa, Inc.
UU201-42-4020
In Commercial Distribution

  • 00810076337289 ()


  • Spinal bone screw, non-bioabsorbable
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