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 Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP2281 ()
  • M719GBP2280 ()

  • Length: 28 Millimeter
GBP2-28

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

  • M719GBP1280 ()
  • M719GBP1281 ()

  • Length: 28 Millimeter
GBP1-28

  • Bone-screw internal spinal fixation system, non-sterile
TWO-LEVEL PLATE TEMPLATE, 28 mm
Xtant Medical Holdings, Inc.
T086-1528
In Commercial Distribution

  • M697T08615280 ()
  • M697T08615281 ()

  • Length: 28 Millimeter


  • Spinal fixation plate, non-bioabsorbable
Irix A 38 x 28 x 19mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382819-12TR
In Commercial Distribution

  • M697T08038281912TR0 ()
  • M697T08038281912TR1 ()

  • Height: 19 Millimeter
  • Length: 28 Millimeter
  • Angle: 12 degree
  • Width: 38 Millimeter


  • Polymeric spinal fusion cage, sterile
Irix A 38 x 28 x 19mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382819-08TR
In Commercial Distribution

  • M697T08038281908TR0 ()
  • M697T08038281908TR1 ()

  • Height: 19 Millimeter
  • Length: 28 Millimeter
  • Width: 38 Millimeter
  • Angle: 8 degree


  • Polymeric spinal fusion cage, sterile
Irix A 38 x 28 x 17mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382817-12TR
In Commercial Distribution

  • M697T08038281712TR0 ()
  • M697T08038281712TR1 ()

  • Angle: 12 degree
  • Width: 38 Millimeter
  • Height: 17 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal fusion cage, sterile
Irix A 38 x 28 x 17mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382817-08TR
In Commercial Distribution

  • M697T08038281708TR0 ()
  • M697T08038281708TR1 ()

  • Width: 38 Millimeter
  • Length: 28 Millimeter
  • Angle: 8 degree
  • Height: 17 Millimeter


  • Polymeric spinal fusion cage, sterile
Irix A 38 x 28 x 15mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382815-12TR
In Commercial Distribution

  • M697T08038281512TR0 ()
  • M697T08038281512TR1 ()

  • Width: 38 Millimeter
  • Angle: 12 degree
  • Length: 28 Millimeter
  • Height: 15 Millimeter


  • Polymeric spinal fusion cage, sterile
Irix A 38 x 28 x 15mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382815-08TR
In Commercial Distribution

  • M697T08038281508TR0 ()
  • M697T08038281508TR1 ()

  • Width: 38 Millimeter
  • Length: 28 Millimeter
  • Angle: 8 degree
  • Height: 15 Millimeter


  • Polymeric spinal fusion cage, sterile
Irix A 38 x 28 x 13mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382813-12TR
In Commercial Distribution

  • M697T08038281312TR0 ()
  • M697T08038281312TR1 ()

  • Length: 28 Millimeter
  • Width: 38 Millimeter
  • Height: 13 Millimeter
  • Angle: 12 degree


  • Polymeric spinal fusion cage, sterile
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