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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No Description
Zimmer, Inc.
00-8701-001-18
In Commercial Distribution

  • 00889024272507 ()

  • Height: 9 Millimeter
  • 18 mm Diameter
00-8701-001-18

  • Elbow radius prosthesis trial
No Description
Zimmer, Inc.
00-8700-001-18
In Commercial Distribution

  • 00889024272262 ()

  • 18 mm Diameter
  • Height: 9 Millimeter
00-8700-001-18

  • Elbow radius prosthesis
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
158
In Commercial Distribution

  • 00850011324158 ()

  • Height: 9 Millimeter
  • Width: 13 Millimeter
VAL-CA-13-09

  • Metallic spinal interbody fusion cage
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
110
In Commercial Distribution

  • 00850011324110 ()

  • Height: 9 Millimeter
  • Width: 10 Millimeter
VAL-CA-10-09

  • Metallic spinal fusion cage, non-sterile
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
20320906K
In Commercial Distribution

  • 00819824028578 ()

  • Angle: 6 degree
  • Height: 9 Millimeter
  • Width: 9 Millimeter
  • Length: 32 Millimeter
20320906K

  • Metallic spinal interbody fusion cage
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
20320900K
In Commercial Distribution

  • 00819824028370 ()

  • Angle: 0 degree
  • Height: 9 Millimeter
  • Width: 9 Millimeter
  • Length: 32 Millimeter
20320900K

  • Metallic spinal interbody fusion cage
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
20270906K
In Commercial Distribution

  • 00819824028479 ()

  • Angle: 6 degree
  • Height: 9 Millimeter
  • Width: 9 Millimeter
  • Length: 27 Millimeter
20270906K

  • Metallic spinal interbody fusion cage
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
20270900K
In Commercial Distribution

  • 00819824028271 ()

  • Angle: 0 degree
  • Height: 9 Millimeter
  • Width: 9 Millimeter
  • Length: 27 Millimeter
20270900K

  • Metallic spinal interbody fusion cage
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
10220900K
In Commercial Distribution

  • 00819824027878 ()

  • Angle: 0 degree
  • Height: 9 Millimeter
  • Width: 9 Millimeter
  • Length: 22 Millimeter
10220900K

  • Metallic spinal interbody fusion cage
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
10260906K
In Commercial Distribution

  • 00819824028172 ()

  • Angle: 6 degree
  • Height: 9 Millimeter
  • Width: 9 Millimeter
  • Length: 26 Millimeter
10260906K

  • Metallic spinal interbody fusion cage
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