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
04-07G
In Commercial Distribution

  • 00819824028691 ()
04-07G

  • Bone graft packing block
The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness
The ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
KWV-StarterKit, Smoke Evacuation starter Kit. Includes Smoke Evacaution unit, Filter and Detecto.
Medisourcenet, Inc
KWV-StarterKit
In Commercial Distribution

  • 00850034735160 ()


  • Surgical plume evacuation system
KWV-LT : KwikVac Liquid Trap / 20pcs in one box
Medisourcenet, Inc
KWV-LT
In Commercial Distribution

  • 00850034735030 ()


  • Surgical plume evacuation system
KWV-F : KwikVac Smoke Evacuation Filter / 1 each
Medisourcenet, Inc
KWV-F
In Commercial Distribution

  • 00850034735023 ()
  • 10850034735020 ()


  • Surgical plume evacuation system
KWV-DT : KwikVac Detecto, Automatic Activation Device / 1 each
Medisourcenet, Inc
KWV-DT
In Commercial Distribution

  • 00850034735016 ()


  • Surgical plume evacuation system
KWV-M : KwikVac Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit (1pc)
Medisourcenet, Inc
KWV-M
In Commercial Distribution

  • 00850034735009 ()


  • Surgical plume evacuation system
TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block
Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block
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