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Company Name Brand Name GMDN Term 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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1 Level, 22mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD1-22
In Commercial Distribution

  • 111106122 ()
  • M364111106FD1220 ()


  • Spinal fixation plate, non-bioabsorbable
1 Level, 20mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD1-20
In Commercial Distribution

  • M364111106FD1200 ()
  • 111106120 ()


  • Spinal fixation plate, non-bioabsorbable
Queen's Square Bladder Stimulator (PC9)
MALEM MEDICAL LIMITED
PC9
In Commercial Distribution

  • 05060049630199 ()


  • Bladder-emptying vibratory stimulator
Queen's Square Bladder Stimulator - Selectable (PC9S)
MALEM MEDICAL LIMITED
PC9S
In Commercial Distribution

  • 05060049630144 ()


  • Bladder-emptying vibratory stimulator
Gait rehabilitation system harness
Liko AB
3666006
In Commercial Distribution

  • 00887761984110 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666005
In Commercial Distribution

  • 00887761984103 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666004
In Commercial Distribution

  • 00887761984097 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564118
In Commercial Distribution

  • 00887761983847 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564117
In Commercial Distribution

  • 00887761983830 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564116
In Commercial Distribution

  • 00887761983823 ()


  • Gait rehabilitation system harness
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