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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 - M697X08038281924STR1

IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382819-24-STR
In Commercial Distribution

  • M697X08038281924STR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 19mm height


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281724STR1

IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-24-STR
In Commercial Distribution

  • M697X08038281724STR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 17mm height


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261924STR1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332619-24-STR
In Commercial Distribution

  • M697X08033261924STR1 ()

  • 26mm depth X 24°, 19mm height
  • Width: 33 Millimeter


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261724STR1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332617-24-STR
In Commercial Distribution

  • M697X08033261724STR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 24°, 17mm height


  • Metal-polymer composite spinal interbody fusion cage

Orthopedic Salvage System (OSS) - 00880304928527

No Description
Biomet Orthopedics, LLC
CP114840
In Commercial Distribution

  • 00880304928527 ()

  • 24 CM 12 CM
CP114840

  • Uncoated knee femur prosthesis, metallic

Orthopedic Salvage System (OSS) - 00880304927476

No Description
Biomet Orthopedics, LLC
CP114851
In Commercial Distribution

  • 00880304927476 ()

  • 24 CM 12 CM
CP114851

  • Uncoated knee femur prosthesis, metallic

Vanguard Knee System - 00880304555921

No Description
Biomet Orthopedics, LLC
189094
In Commercial Distribution

  • 00880304555921 ()

  • 24 MM 75 MM
189094

  • Tibial insert

ORTHOPEDIC SALVAGE SYSTEM - 00880304687998

No Description
Biomet Orthopedics, LLC
151865
In Commercial Distribution

  • 00880304687998 ()

  • 14MM Ø 24 CM
151865

  • Femur/tibia shaft prosthesis

VANGUARD SSK 360 KNEE SYSTEM - 00880304481398

No Description
Biomet Orthopedics, LLC
185174
In Commercial Distribution

  • 00880304481398 ()

  • 24 MM 59 MM
185174

  • Tibial insert

VANGUARD SSK 360 KNEE SYSTEM - 00880304481312

No Description
Biomet Orthopedics, LLC
185154
In Commercial Distribution

  • 00880304481312 ()

  • 24 MM 59 MM
185154

  • Tibial insert
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