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 INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 12°, 13mm, PC
Xtant Medical Holdings, Inc.
X080-382813-12TPC
Not in Commercial Distribution

  • M697X08038281312TPC1 ()

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


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 8°, 13mm, PC
Xtant Medical Holdings, Inc.
X080-382813-08TPC
Not in Commercial Distribution

  • M697X08038281308TPC1 ()

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


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 12°, 11mm, PC
Xtant Medical Holdings, Inc.
X080-382811-12TPC
Not in Commercial Distribution

  • M697X08038281112TPC1 ()

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


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 8°, 11mm, PC
Xtant Medical Holdings, Inc.
X080-382811-08TPC
Not in Commercial Distribution

  • M697X08038281108TPC1 ()

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


  • Metallic spinal interbody fusion cage
IDENTITI ALIF POROUS TI SPACER, SW, 5 X 38 X 28 MM, 15°
ALPHATEC SPINE, INC.
104-05382815-S
In Commercial Distribution

  • 00190376159201 ()

  • Angle: 15 degree
  • Depth: 28 Millimeter
  • Height: 5 Millimeter
  • Width: 38 Millimeter


  • Metallic spinal interbody fusion cage
IDENTITI ALIF POROUS TI SPACER, SW, 5 X 38 X 28 MM, 10°
ALPHATEC SPINE, INC.
104-05382810-S
In Commercial Distribution

  • 00190376159195 ()

  • Depth: 28 Millimeter
  • Width: 38 Millimeter
  • Height: 5 Millimeter
  • Angle: 10 degree


  • Metallic spinal interbody fusion cage
IDENTITI ALIF POROUS TI SPACER, SW, 5 x 38 x 28 mm, 15°
ALPHATEC SPINE, INC.
204-05382815-S
In Commercial Distribution

  • 00190376290263 ()

  • Width: 38 Millimeter
  • Angle: 15 degree
  • Height: 5 Millimeter
  • Depth: 28 Millimeter


  • Metallic spinal interbody fusion cage
IDENTITI ALIF POROUS TI SPACER, SW, 5 x 38 x 28 mm, 10°
ALPHATEC SPINE, INC.
204-05382810-S
In Commercial Distribution

  • 00190376290249 ()

  • Angle: 10 degree
  • Width: 38 Millimeter
  • Depth: 28 Millimeter
  • Height: 5 Millimeter


  • Metallic spinal interbody fusion cage
IDENTITI ALIF POROUS TI SPACER, SW, 11 x 38 x 28 mm, 15°
ALPHATEC SPINE, INC.
204-11382815-S
In Commercial Distribution

  • 00190376290072 ()

  • Height: 11 Millimeter
  • Width: 38 Millimeter
  • Depth: 28 Millimeter
  • Angle: 15 degree


  • Metallic spinal interbody fusion cage
IDENTITI ALIF POROUS TI SPACER, SW, 11 x 38 x 28 mm, 10°
ALPHATEC SPINE, INC.
204-11382810-S
In Commercial Distribution

  • 00190376290058 ()

  • Height: 11 Millimeter
  • Depth: 28 Millimeter
  • Width: 38 Millimeter
  • Angle: 10 degree


  • Metallic spinal interbody fusion cage
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