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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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The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
MET 1 TECHNOLOGIES, LLC
10220700K
In Commercial Distribution

  • 00819824027854 ()

  • Angle: 0 degree
  • Height: 7 Millimeter
  • Width: 9 Millimeter
  • Length: 22 Millimeter
10220700K

  • Metallic spinal interbody fusion cage
FORTILINK-C Tetrafuse 12x14 11mm, 6L
Pioneer Surgical Technology, Inc.
65-C-1214-11-6L
Not in Commercial Distribution

  • 00846468080396 ()

  • 12mm (D), 14mm (W), 11mm (H), 6° Lordosis
65-C-1214-11-6L

  • Metallic spinal interbody fusion cage
  • Vertebral body prosthesis
FORTILINK-C Tetrafuse 12x14 7mm, 6L
Pioneer Surgical Technology, Inc.
65-C-1214-7-6L
Not in Commercial Distribution

  • 00846468080358 ()

  • 12mm (D), 14mm (W), 7mm (H), 6° Lordosis
65-C-1214-7-6L

  • Metallic spinal interbody fusion cage
  • Vertebral body prosthesis
FORTILINK-C Tetrafuse 12x14 5mm, 6L
Pioneer Surgical Technology, Inc.
65-C-1214-5-6L
Not in Commercial Distribution

  • 00846468080334 ()

  • 12mm (D), 14mm (W), 5mm (H), 6° Lordosis
65-C-1214-5-6L

  • Metallic spinal interbody fusion cage
  • Vertebral body prosthesis
FORTILINK-C Tetrafuse 10x12 8mm, 6L
Pioneer Surgical Technology, Inc.
65-C-1012-8-6L
Not in Commercial Distribution

  • 00846468080297 ()

  • 10mm (D), 12mm (W), 8mm (H), 6° Lordosis
65-C-1012-8-6L

  • Metallic spinal interbody fusion cage
  • Vertebral body prosthesis
FORTILINK-C Tetrafuse 10x12 5mm, 6L
Pioneer Surgical Technology, Inc.
65-C-1012-5-6L
Not in Commercial Distribution

  • 00846468080204 ()

  • 10mm (D), 12mm (W), 5mm (H), 6° Lordosis
65-C-1012-5-6L

  • Metallic spinal interbody fusion cage
  • Vertebral body prosthesis
FORTILINK-C Tetrafuse 14.5x17 11mm, 6L
Pioneer Surgical Technology, Inc.
65-C-1517-11-6L
Not in Commercial Distribution

  • 00846468080464 ()

  • 14.5mm (D), 17mm (W), 11mm (H), 6° Lordosis
65-C-1517-11-6L

  • Metallic spinal interbody fusion cage
  • Vertebral body prosthesis
FORTILINK-C Tetrafuse 14.5x17 10mm, 6L
Pioneer Surgical Technology, Inc.
65-C-1517-10-6L
Not in Commercial Distribution

  • 00846468080457 ()

  • 14.5mm (D), 17mm (W), 10mm (H), 6° Lordosis
65-C-1517-10-6L

  • Metallic spinal interbody fusion cage
  • Vertebral body prosthesis
FORTILINK-C Tetrafuse 14.5x17 8mm, 6L
Pioneer Surgical Technology, Inc.
65-C-1517-8-6L
Not in Commercial Distribution

  • 00846468080433 ()

  • 14.5mm (D), 17mm (W), 8mm (H), 6° Lordosis
65-C-1517-8-6L

  • Metallic spinal interbody fusion cage
  • Vertebral body prosthesis
FORTILINK-C Tetrafuse 14.5x17 5mm, 6L
Pioneer Surgical Technology, Inc.
65-C-1517-5-6L
Not in Commercial Distribution

  • 00846468080402 ()

  • 14.5mm (D), 17mm (W), 5mm (H), 6° Lordosis
65-C-1517-5-6L

  • Metallic spinal interbody fusion cage
  • Vertebral body prosthesis
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