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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3 Level, 75mm 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-FD3-75
In Commercial Distribution

  • 111106375 ()
  • M364111106FD3750 ()


  • Spinal fixation plate, non-bioabsorbable
3 Level, 66mm 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-FD3-66
In Commercial Distribution

  • 111106366 ()
  • M364111106FD3660 ()


  • Spinal fixation plate, non-bioabsorbable
3 Level, 63mm 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-FD3-63
In Commercial Distribution

  • 111106363 ()
  • M364111106FD3630 ()


  • Spinal fixation plate, non-bioabsorbable
3 Level, 57mm 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-FD3-57
In Commercial Distribution

  • 111106357 ()
  • M364111106FD3570 ()


  • Spinal fixation plate, non-bioabsorbable
3 Level, 51mm 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-FD3-51
In Commercial Distribution

  • 111106351 ()
  • M364111106FD3510 ()


  • Spinal fixation plate, non-bioabsorbable
2 Level, 50mm 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-FD2-50
In Commercial Distribution

  • 111106250 ()
  • M364111106FD2500 ()


  • Spinal fixation plate, non-bioabsorbable
2 Level, 47mm 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-FD2-47
In Commercial Distribution

  • 111106247 ()
  • M364111106FD2470 ()


  • Spinal fixation plate, non-bioabsorbable
2 Level, 44mm 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-FD2-44
In Commercial Distribution

  • 111106244 ()
  • M364111106FD2440 ()


  • Spinal fixation plate, non-bioabsorbable
2 Level, 41mm 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-FD2-41
In Commercial Distribution

  • 111106241 ()
  • M364111106FD2410 ()


  • Spinal fixation plate, non-bioabsorbable
2 Level, 35mm 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-FD2-35
In Commercial Distribution

  • 111106235 ()
  • M364111106FD2350 ()


  • Spinal fixation plate, non-bioabsorbable
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, 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, 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
EQM-A : EvaQMax Auto Automatic Activation Device / 1 each/ reusable
MEDIMAX TECH INC.
EQM-A
In Commercial Distribution

  • 00817325023610 ()


  • Surgical plume evacuation system
EQM-FT : EvaQMax Fluid Trap - Fluid Trap for Unit / 20 pcs in one box / Each
MEDIMAX TECH INC.
EQM-FT
In Commercial Distribution

  • 00817325023603 ()


  • Surgical plume evacuation system
EQM-CAF : EvaQMax Filter for the EvaQMax Unit / each/ reusable
MEDIMAX TECH INC.
EQM-CAF
In Commercial Distribution

  • 10817325023570 ()
  • 00817325023573 ()


  • Surgical plume evacuation system
GAIT BELT,YELLOW,FALL MGMT,72" 1EA
MEDLINE INDUSTRIES, INC.
MDT821203YL
In Commercial Distribution

  • 10080196374779 ()
MDT821203YL

  • Gait rehabilitation system harness
BLOCK EX0917036 S.S. LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
EX0917036
In Commercial Distribution

  • 00763000134679 ()


  • Bone graft packing block
STATION EX0718010 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0718010
In Commercial Distribution

  • 00763000186319 ()


  • Bone graft packing block
STATION X0516086 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X0516086
In Commercial Distribution

  • 00763000177669 ()


  • Bone graft packing block
STATION X0314002 DUL SIDED GRFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X0314002
In Commercial Distribution

  • 00763000177645 ()


  • Bone graft packing block
PACKING STATION EX0818003 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0818003
In Commercial Distribution

  • 00763000216948 ()


  • Bone graft packing block
BLOCK 4680011 LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
4680011
In Commercial Distribution

  • 00763000194000 ()


  • Bone graft packing block
STATION EX0420049 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0420049
In Commercial Distribution

  • 00763000387068 ()


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

  • 00763000056223 ()


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

  • 00763000371777 ()


  • Bone graft packing block
IMPACTOR EX0312181 GRAFT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX0312181
In Commercial Distribution

  • 00643169190108 ()


  • Bone graft packing block
POSITIONER EX0512197 LARGE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0512197
In Commercial Distribution

  • 00643169181526 ()


  • Bone graft packing block
GUN EX1112020 GRAFT DELIVERY
MEDTRONIC SOFAMOR DANEK, INC.
EX1112020
In Commercial Distribution

  • 00643169293892 ()


  • Bone graft packing block
LID 7426010 PACKING FIXTURE
MEDTRONIC SOFAMOR DANEK, INC.
7426010
In Commercial Distribution

  • 00643169572645 ()


  • Bone graft packing block
FIXTURE 7426009 IMPLANT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
7426009
In Commercial Distribution

  • 00643169572638 ()


  • Bone graft packing block
PACKING EX0112072 40-45-50-55GRAFT STATN
MEDTRONIC SOFAMOR DANEK, INC.
EX0112072
In Commercial Distribution

  • 00643169149663 ()


  • Bone graft packing block
PACKING EX0112070 22-26-32-36GRAFT STATN
MEDTRONIC SOFAMOR DANEK, INC.
EX0112070
In Commercial Distribution

  • 00643169149656 ()


  • Bone graft packing block
PACKING EX0112069 25-30-36 GRAFT STATION
MEDTRONIC SOFAMOR DANEK, INC.
EX0112069
In Commercial Distribution

  • 00643169149649 ()


  • Bone graft packing block
STATION X1213073 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X1213073
In Commercial Distribution

  • 00643169448155 ()


  • Bone graft packing block
STATION X1213075 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X1213075
In Commercial Distribution

  • 00643169445116 ()


  • Bone graft packing block
STATION X1213074 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X1213074
In Commercial Distribution

  • 00643169445109 ()


  • Bone graft packing block
POSITIONER EX0911187 NO-STOP
MEDTRONIC SOFAMOR DANEK, INC.
EX0911187
In Commercial Distribution

  • 00643169089174 ()


  • Bone graft packing block
POSITIONER EX0911186 3MM-STOP
MEDTRONIC SOFAMOR DANEK, INC.
EX0911186
In Commercial Distribution

  • 00643169089167 ()


  • Bone graft packing block
PACKING STATION EX0315064 CR GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0315064
In Commercial Distribution

  • 00643169631007 ()


  • Bone graft packing block
BLOCK EX0815056 LOADING 5 6 7 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0815056
In Commercial Distribution

  • 00643169671942 ()


  • Bone graft packing block
IMPACTOR X807-914 ANGLED GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
X807-914
In Commercial Distribution

  • 00673978158327 ()


  • Bone graft packing block
THREADED GRAFT SQUARE
MEDTRONIC SOFAMOR DANEK, INC.
X0596-011
In Commercial Distribution

  • 00673978140513 ()


  • Bone graft packing block
THREADED GRAFT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0596-010
In Commercial Distribution

  • 00673978140506 ()


  • Bone graft packing block
IMPACTOR X0411311 GRAFT 45 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411311
In Commercial Distribution

  • 00613994994998 ()


  • Bone graft packing block
IMPACTOR X0411310 GRAFT 15 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411310
In Commercial Distribution

  • 00613994994981 ()


  • Bone graft packing block
PUSHER X0411304 GRAFT MEDIUM
MEDTRONIC SOFAMOR DANEK, INC.
X0411304
In Commercial Distribution

  • 00613994994974 ()


  • Bone graft packing block
PUSHER X0411303 GRAFT SMALL
MEDTRONIC SOFAMOR DANEK, INC.
X0411303
In Commercial Distribution

  • 00613994994967 ()


  • Bone graft packing block
LOADING BLOCK EX0311274 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0311274
In Commercial Distribution

  • 00613994992543 ()


  • Bone graft packing block
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