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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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Diameter 4.75 x 35 mm Pedicle Screw
Ortho Development Corporation
158-4735-01
Not in Commercial Distribution

  • 00822409030637 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 4.75 x 30 mm Pedicle Screw
Ortho Development Corporation
158-4730-01
Not in Commercial Distribution

  • 00822409030620 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 30 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 4.75 x 25 mm Pedicle Screw
Ortho Development Corporation
158-4725-01
Not in Commercial Distribution

  • 00822409030613 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 4.75 x 20 mm Pedicle Screw
Ortho Development Corporation
158-4720-01
Not in Commercial Distribution

  • 00822409030606 ()

  • Length: 20 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Spinal bone screw, non-bioabsorbable
Transverse Connector, Short
Ortho Development Corporation
158-4050
Not in Commercial Distribution

  • 00822409030590 ()


  • Bone-screw internal spinal fixation system connector
No Description
Innosys Co., Ltd.
SH0507-A7
In Commercial Distribution

  • 08800037523150 ()


  • Spinal implant trial
No Description
Innosys Co., Ltd.
SH0023
In Commercial Distribution

  • 08800037523143 ()


  • Spinal implant trial
No Description
Innosys Co., Ltd.
SH0022
In Commercial Distribution

  • 08800037523136 ()


  • Spinal implant trial
No Description
BIOMET SPINE LLC
14-500785
In Commercial Distribution

  • 03662663058292 ()

  • DOMINO, SS 6.35MMX6.35MM AXIAL
14-500785

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
14-500784
In Commercial Distribution

  • 03662663058285 ()

  • 6.0MM X 6.35MM AXIAL SST DOMINO
14-500784

  • Bone-screw internal spinal fixation system, non-sterile
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