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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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Irix-A Lumbar Integrated Fusion System - M697X08033261324TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 13mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332613-24T-STR
In Commercial Distribution

  • M697X08033261324TSTR1 ()

  • 26mm depth X 24°, 13mm height
  • Width: 33 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301924TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-24T-STR
In Commercial Distribution

  • M697X08042301924TSTR1 ()

  • 30mm depth X 24°, 19mm height
  • Width: 42 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301924STR1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-24-STR
In Commercial Distribution

  • M697X08042301924STR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 24°, 19mm height


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301524TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423015-24T-STR
In Commercial Distribution

  • M697X08042301524TSTR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 24°, 15mm height


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281524TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382815-24T-STR
In Commercial Distribution

  • M697X08038281524TSTR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 15mm height


  • Metallic spinal interbody fusion cage

MIC PEG TUBE - 00350770006192

MIC* Safety Percutaneous Endoscopic Gastrostomy PEG Kit - 24 Fr - PUSH OTW
Avanos Medical, Inc.
7170-24
In Commercial Distribution

  • 10350770006199 ()
  • 00350770006192 ()
7170-24

  • Gastrostomy tube

neon³ CT spinal stabilization - 04052536084463

Screw, cannulated, favored angle medial, Ø 4.0 mm, length 24 mm
Ulrich GmbH & Co. KG
CS 3906-40-24
In Commercial Distribution

  • 04052536084463 ()
CS 3906-40-24

  • Spinal bone screw, non-bioabsorbable

VBR™ vertebral body replacement - 04052536076048

VBR center piece, size M, Ø 24 mm, height 74-114 mm
Ulrich GmbH & Co. KG
CS 2224-741141
Not in Commercial Distribution

  • 04052536076048 ()
CS 2224-741141

  • Vertebral body prosthesis

VBR™ vertebral body replacement - 04052536003839

VBR center piece, size L, Ø 24 mm, height 52-76 mm
Ulrich GmbH & Co. KG
CS 2224-5276-1
Not in Commercial Distribution

  • 04052536003839 ()
CS 2224-5276-1

  • Vertebral body prosthesis

VBR™ vertebral body replacement - 04052536003761

VBR center piece, size K, Ø 24 mm, height 38-54 mm
Ulrich GmbH & Co. KG
CS 2224-3854-1
Not in Commercial Distribution

  • 04052536003761 ()
CS 2224-3854-1

  • Vertebral body prosthesis
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