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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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50mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD6
In Commercial Distribution

  • 1111096 ()
  • M364111109FD6 ()

  • Outer Diameter: 9 Millimeter
  • Length: 50 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
45mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD5
In Commercial Distribution

  • 1111095 ()
  • M364111109FD50 ()

  • Outer Diameter: 9 Millimeter
  • Length: 45 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
40mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD4
In Commercial Distribution

  • 1111094 ()
  • M364111109FD40 ()

  • Outer Diameter: 9 Millimeter
  • Length: 40 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
35mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD3
In Commercial Distribution

  • 1111093 ()
  • M364111109FD30 ()

  • Outer Diameter: 9 Millimeter
  • Length: 35 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
30mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD2
In Commercial Distribution

  • M364111109FD20 ()
  • 1111092 ()

  • Length: 30 Millimeter
  • Outer Diameter: 9 Millimeter
11-1109-FD2

  • Sacroiliac joint intra-articular arthrodesis implant
4 Level, 94mm 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-FD4-94
In Commercial Distribution

  • 111106494 ()
  • M364111106FD4940 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 90mm 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-FD4-90
In Commercial Distribution

  • 111106490 ()
  • M364111106FD4900 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 86mm 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-FD4-86
In Commercial Distribution

  • 111106486 ()
  • M364111106FD4860 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 82mm 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-FD4-82
In Commercial Distribution

  • 111106482 ()
  • M364111106FD4820 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 78mm 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-FD4-78
In Commercial Distribution

  • 111106478 ()
  • M364111106FD4780 ()


  • Spinal fixation plate, non-bioabsorbable
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