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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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Dual
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP220450 ()

  • Width: 4.5 Millimeter
  • Length: 20 Millimeter
GBP2-2045

  • Bone-screw internal spinal fixation system, non-sterile
Single
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP120600 ()

  • Length: 20 Millimeter
  • Width: 6.0 Millimeter
GBP1-2060

  • Bone-screw internal spinal fixation system, non-sterile
Single
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP120550 ()

  • Width: 5.5 Millimeter
  • Length: 20 Millimeter
GBP1-2055

  • Bone-screw internal spinal fixation system, non-sterile
Small Titanium ALIF
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GATI20S120 ()

  • Angle: 12 degree
  • Height: 20 Millimeter
GATi-20-S12

  • Lumbar interspinous decompression spacer, non-sterile
Small Titanium ALIF
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GATI20S060 ()

  • Angle: 6 degree
  • Height: 20 Millimeter
GATi-20-S06

  • Lumbar interspinous decompression spacer, non-sterile
Medium Titanium ALIF
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GATI20M120 ()

  • Angle: 12 degree
  • Height: 20 Millimeter
GATi-20-M12

  • Lumbar interspinous decompression spacer, non-sterile
Medium Titanium ALIF
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GATI20M060 ()

  • Angle: 6 degree
  • Height: 20 Millimeter
GATi-20-M06

  • Lumbar interspinous decompression spacer, non-sterile
Large Titanium ALIF
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GATI20L120 ()

  • Height: 20 Millimeter
  • Angle: 12 degree
GATi-20-L12

  • Lumbar interspinous decompression spacer, non-sterile
Large Titanium ALIF
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GATI20L060 ()

  • Height: 20 Millimeter
  • Angle: 6 degree
GATi-20-L06

  • Lumbar interspinous decompression spacer, non-sterile
Small 3DP ALIF 20mm x 12 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GA3D2012S0 ()

  • Height: 20 Millimeter
  • Angle: 12 degree
GA3D-2012S

  • Metallic spinal fusion cage, non-sterile
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