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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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The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GXMS-5550
In Commercial Distribution

  • 08809255540062 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GXMS-5545
In Commercial Distribution

  • 08809255540055 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GXMS-5540
In Commercial Distribution

  • 08809255540048 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GXMS-5535
In Commercial Distribution

  • 08809255540031 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GXMS-5530
In Commercial Distribution

  • 08809255540024 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. The system is indicated for fixation of bone fractures or bone reconstruction. Instruments are provided for guidance of implants.
NEWDEAL
TIBIAXYSSET
Not in Commercial Distribution

  • 10381780064466 ()
  • M248TIBIAXYSSET1 ()
TIBIAXYSSET

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
WASHER DISINFECTOR 46-5 S+W D, S+W D indicating a single door washer disinfector with dryer. This is a customized version of 46-5-402 with water inlet through the roof plate and signal exchange for external valve for treated water.
Getinge Disinfection AB
46-5
In Commercial Distribution

  • 07340153710252 ()
46-5-402K977

  • Surgical utensil washer/disinfector
WASHER DISINFECTOR 46-5 S+W D, S+W D indicating a single door washer disinfector with dryer. This is a customized version of 46-5-402 with water inlet through the roof plate and signal exchange for external valve for treated water.
Getinge Disinfection AB
46-5
In Commercial Distribution

  • 07340153710146 ()
46-5-402K962

  • Surgical utensil washer/disinfector
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
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
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