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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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
Irix A 38 x 28 x 13mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382813-08TR
In Commercial Distribution

  • M697T08038281308TR0 ()
  • M697T08038281308TR1 ()

  • Width: 38 Millimeter
  • Height: 13 Millimeter
  • Angle: 8 degree
  • Length: 28 Millimeter


  • Polymeric spinal fusion cage, sterile
Irix A 38 x 28 x 11mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382811-12TR
In Commercial Distribution

  • M697T08038281112TR0 ()
  • M697T08038281112TR1 ()

  • Angle: 12 degree
  • Length: 28 Millimeter
  • Width: 38 Millimeter
  • Height: 11 Millimeter


  • Polymeric spinal fusion cage, sterile
Irix A 38 x 28 x 11mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382811-08TR
In Commercial Distribution

  • M697T08038281108TR0 ()
  • M697T08038281108TR1 ()

  • Angle: 8 degree
  • Height: 11 Millimeter
  • Length: 28 Millimeter
  • Width: 38 Millimeter


  • Polymeric spinal fusion cage, sterile
IMPLANT INSERTER TIP, 38 x 28mm
Xtant Medical Holdings, Inc.
T080-3828
In Commercial Distribution

  • M697T08038280 ()
  • M697T08038281 ()

  • Width: 38 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal fusion cage, sterile
Irix A 8mm Bone Rongeur
Xtant Medical Holdings, Inc.
T080-0100-7
In Commercial Distribution

  • M697T080010070 ()
  • M697T080010071 ()

  • Width: 8 Millimeter


  • Polymeric spinal fusion cage, sterile
Irix A 8mm Pituitary Rongeur
Xtant Medical Holdings, Inc.
T080-0100-6
In Commercial Distribution

  • M697T080010060 ()
  • M697T080010061 ()

  • Width: 8 Millimeter


  • Polymeric spinal fusion cage, sterile
MODULAR TIP, LOCKING PLATE, 28mm; ALL-IN-ONE PARALLEL INSERTER AXLE X SYSTEM
Xtant Medical Holdings, Inc.
X060-6028LX
In Commercial Distribution

  • M697X0606028LX0 ()
  • M697X0606028LX1 ()

  • Length: 28 Millimeter


  • Lumbar interspinous decompression instrument set, reusable
MODULAR TIP, LOCKING PLATE, 28mm; ALL-IN-ONE PARALLEL INSERTER AXLES SYSTEM
Xtant Medical Holdings, Inc.
X060-6028L
In Commercial Distribution

  • M697X0606028L0 ()
  • M697X0606028L1 ()

  • Length: 28 Millimeter


  • Lumbar interspinous decompression instrument set, reusable
Axle All-In-One Parallel, Modular Tip, Cross Bar Plate, 28mm
Xtant Medical Holdings, Inc.
X060-6028C
In Commercial Distribution

  • M697X0606028C0 ()
  • M697X0606028C1 ()

  • Length: 28 Millimeter


  • Lumbar interspinous decompression instrument set, reusable
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