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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BIOMET SPINE LLC
14-531171
In Commercial Distribution

  • 00880304911451 ()

  • Parallel 14 x 12 x 11 mm PEEK Spacer with X-Ray Markers
14-531171

  • Vertebral body prosthesis
No Description
BIOMET SPINE LLC
14-531161
In Commercial Distribution

  • 00880304911376 ()

  • Lordotic 18 x 16 x 11 mm PEEK Spacer with X-Ray Markers
14-531161

  • Vertebral body prosthesis
THE MET ONE TECHNOLOGIES KODIAK C SPINAL VERTEBRAL BODY REPLACEMENT DEVICE IS A THORACOLUMBAR VERTEBRAL BODY REPLACEMENT DEVICE THAT IS IMPLANTED TO ACHIEVE ANTERIOR DECOMPRESSION OF THE SPINAL CORD AND NEURAL TISSUES AND TO RESTORE THE HEIGHT OF A COLLAPSED VERTEBRAL BODY. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
41112406K
In Commercial Distribution

  • 00819824026444 ()

  • Angle: 6 degree
  • Height: 11 Millimeter
  • Width: 14 Millimeter
  • Length: 12 Millimeter
41112406K

  • Vertebral body prosthesis
THE MET ONE TECHNOLOGIES KODIAK C SPINAL VERTEBRAL BODY REPLACEMENT DEVICE IS A THORACOLUMBAR VERTEBRAL BODY REPLACEMENT DEVICE THAT IS IMPLANTED TO ACHIEVE ANTERIOR DECOMPRESSION OF THE SPINAL CORD AND NEURAL TISSUES AND TO RESTORE THE HEIGHT OF A COLLAPSED VERTEBRAL BODY. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
41112400K
In Commercial Distribution

  • 00819824025423 ()

  • Angle: 0 degree
  • Height: 11 Millimeter
  • Width: 14 Millimeter
  • Length: 12 Millimeter
41112400K

  • Vertebral body prosthesis
THE MET ONE TECHNOLOGIES KODIAK C SPINAL VERTEBRAL BODY REPLACEMENT DEVICE IS A THORACOLUMBAR VERTEBRAL BODY REPLACEMENT DEVICE THAT IS IMPLANTED TO ACHIEVE ANTERIOR DECOMPRESSION OF THE SPINAL CORD AND NEURAL TISSUES AND TO RESTORE THE HEIGHT OF A COLLAPSED VERTEBRAL BODY. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
41114606K
In Commercial Distribution

  • 00819824026956 ()

  • Angle: 6 degree
  • Height: 11 Millimeter
  • Width: 16 Millimeter
  • Length: 14 Millimeter
41114606K

  • Vertebral body prosthesis
THE MET ONE TECHNOLOGIES KODIAK C SPINAL VERTEBRAL BODY REPLACEMENT DEVICE IS A THORACOLUMBAR VERTEBRAL BODY REPLACEMENT DEVICE THAT IS IMPLANTED TO ACHIEVE ANTERIOR DECOMPRESSION OF THE SPINAL CORD AND NEURAL TISSUES AND TO RESTORE THE HEIGHT OF A COLLAPSED VERTEBRAL BODY. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
41114600K
In Commercial Distribution

  • 00819824025935 ()

  • Angle: 0 degree
  • Height: 11 Millimeter
  • Width: 16 Millimeter
  • Length: 14 Millimeter
41114600K

  • Vertebral body prosthesis
TL - PEEK 5 DEGREES LARGE SPACER - 28MMX10MMX11MM
ALPHATEC SPINE, INC.
64616-111
In Commercial Distribution

  • 00844856013858 ()

  • Length: 28 Millimeter
  • Height: 11 Millimeter
  • Angle: 5 degree
  • Width: 10 Millimeter


  • Polymeric spinal interbody fusion cage
  • Vertebral body prosthesis
NOVEL TL, SPINAL SPACER, MEDIUM 5° LORDOTIC, 11MM
ALPHATEC SPINE, INC.
64614-111
In Commercial Distribution

  • 00844856013636 ()

  • Width: 10 Millimeter
  • Angle: 5 degree
  • Length: 24 Millimeter
  • Height: 11 Millimeter


  • Polymeric spinal interbody fusion cage
  • Vertebral body prosthesis
TL - PEEK 5 DEGREES SMALL SPACER - 22MMX10MMX11MM
ALPHATEC SPINE, INC.
64612-111
In Commercial Distribution

  • 00844856013445 ()

  • Angle: 5 degree
  • Height: 11 Millimeter
  • Length: 22 Millimeter
  • Width: 10 Millimeter


  • Vertebral body prosthesis
  • Polymeric spinal interbody fusion cage
NOVEL CP L-5, 46MM, PEEK
ALPHATEC SPINE, INC.
64757-146
In Commercial Distribution

  • 00844856018624 ()

  • Length: 20 Millimeter
  • Width: 18 Millimeter
  • Height: 46 Millimeter
  • Angle: 11 degree


  • Vertebral body prosthesis
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