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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
04-2208P0
In Commercial Distribution

  • 00819824028714 ()
04-2208P0

  • Spinal implant trial
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
07-0014G
In Commercial Distribution

  • 00819824027489 ()
07-0014G

  • Spinal implant trial
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
07-0013G
In Commercial Distribution

  • 00819824027472 ()
07-0013G

  • Spinal implant trial
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
07-0012F
In Commercial Distribution

  • 00819824027465 ()
07-0012F

  • Spinal implant trial
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
07-0011F
In Commercial Distribution

  • 00819824027458 ()
07-0011F

  • Spinal implant trial
THE MET ONE TECHNOLOGIES KODIAK C SPINAL INTERVERTEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVERTEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE VERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
07-0042J
In Commercial Distribution

  • 00819824027762 ()
07-0042J

  • Spinal implant trial
THE MET ONE TECHNOLOGIES KODIAK C SPINAL INTERVERTEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVERTEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE VERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
07-0041J
In Commercial Distribution

  • 00819824027755 ()
07-0041J

  • Spinal implant trial
THE MET ONE TECHNOLOGIES KODIAK C SPINAL INTERVERTEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVERTEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE VERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
07-0040J
In Commercial Distribution

  • 00819824027748 ()
07-0040J

  • Spinal implant trial
THE MET ONE TECHNOLOGIES KODIAK C SPINAL INTERVERTEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVERTEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE VERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
07-0039J
In Commercial Distribution

  • 00819824027731 ()
07-0039J

  • Spinal implant trial
THE MET ONE TECHNOLOGIES KODIAK C SPINAL INTERVERTEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVERTEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE VERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
07-0038J
In Commercial Distribution

  • 00819824027724 ()
07-0038J

  • Spinal implant trial
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