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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1 Level, 30mm 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-FD1-30
In Commercial Distribution

  • 111106130 ()
  • M364111106FD1300 ()


  • Spinal fixation plate, non-bioabsorbable
1 Level, 28mm 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-FD1-28
In Commercial Distribution

  • 111106128 ()
  • M364111106FD1280 ()


  • Spinal fixation plate, non-bioabsorbable
1 Level, 26mm 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-FD1-26
In Commercial Distribution

  • 111106126 ()
  • M364111106FD1260 ()


  • Spinal fixation plate, non-bioabsorbable
1 Level, 24mm 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-FD1-24
In Commercial Distribution

  • 111106124 ()
  • M364111106FD1240 ()


  • Spinal fixation plate, non-bioabsorbable
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
STATION EX0420049 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0420049
In Commercial Distribution

  • 00763000387068 ()


  • Bone graft packing block
STATION EX0220045 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0220045
In Commercial Distribution

  • 00763000371777 ()


  • Bone graft packing block
STATION EX0717016 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0717016
In Commercial Distribution

  • 00763000056223 ()


  • Bone graft packing block
BLOCK EX0917036 S.S. LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
EX0917036
In Commercial Distribution

  • 00763000134679 ()


  • Bone graft packing block
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