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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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EARP Interbody System - 00810135960007

EARP, 14X25X08 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP1425-0008
Not in Commercial Distribution

  • 00810135960007 ()

  • Depth: 14 Millimeter
  • Width: 25 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage

ShurFit Interbody Device - 00840019937795

PLIF 15 Deg System Kit
PRECISION SPINE, INC.
49-BK-0100
In Commercial Distribution

  • 00840019937795 ()
49-BK-0100

  • IVF medium
  • Polymeric spinal interbody fusion cage

Novel - 00844856019133

SD - TI SMALL CAGE - 9MMX22MMX13MM
ALPHATEC SPINE, INC.
64803-013
In Commercial Distribution

  • 00844856019133 ()

  • Length: 22 Millimeter
  • Height: 13 Millimeter
  • Width: 9 Millimeter


  • Polymeric spinal interbody fusion cage
  • Vertebral body prosthesis

Novel - 00844856019126

SD - TI SMALL CAGE - 9MMX22MMX12MM
ALPHATEC SPINE, INC.
64803-012
In Commercial Distribution

  • 00844856019126 ()

  • Length: 22 Millimeter
  • Width: 9 Millimeter
  • Height: 12 Millimeter


  • Polymeric spinal interbody fusion cage
  • Vertebral body prosthesis

Novel - 00844856019119

SD - TI SMALL CAGE - 9MMX22MMX11MM
ALPHATEC SPINE, INC.
64803-011
In Commercial Distribution

  • 00844856019119 ()

  • Height: 11 Millimeter
  • Length: 22 Millimeter
  • Width: 9 Millimeter


  • Vertebral body prosthesis
  • Polymeric spinal interbody fusion cage

Novel - 00844856019102

SD - TI SMALL CAGE - 9MMX22MMX10MM
ALPHATEC SPINE, INC.
64803-010
In Commercial Distribution

  • 00844856019102 ()

  • Length: 22 Millimeter
  • Height: 10 Millimeter
  • Width: 9 Millimeter


  • Vertebral body prosthesis
  • Polymeric spinal interbody fusion cage

Novel - 00844856019096

SD - TI SMALL CAGE - 9MMX22MMX9MM
ALPHATEC SPINE, INC.
64803-009
In Commercial Distribution

  • 00844856019096 ()

  • Length: 22 Millimeter
  • Height: 9 Millimeter
  • Width: 9 Millimeter


  • Vertebral body prosthesis
  • Polymeric spinal interbody fusion cage

Novel - 00844856019089

SD - TI SMALL CAGE - 9MMX22MMX8MM
ALPHATEC SPINE, INC.
64803-008
In Commercial Distribution

  • 00844856019089 ()

  • Length: 22 Millimeter
  • Width: 9 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage
  • Vertebral body prosthesis

Novel - 00844856014879

SPINAL SPACER, LARGE, TAPERED, LORDOTIC, 15MM, NOVEL, TL
ALPHATEC SPINE, INC.
64659-115
Not in Commercial Distribution

  • 00844856014879 ()


  • Polymeric spinal interbody fusion cage
  • Vertebral body prosthesis

Novel - 00844856014862

SPINAL SPACER, LARGE, TAPERED, LORDOTIC, 14MM, NOVEL, TL
ALPHATEC SPINE, INC.
64659-114
Not in Commercial Distribution

  • 00844856014862 ()


  • Polymeric spinal interbody fusion cage
  • Vertebral body prosthesis
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