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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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Medtronic Reusable Instruments - 00643169149649

PACKING EX0112069 25-30-36 GRAFT STATION
MEDTRONIC SOFAMOR DANEK, INC.
EX0112069
In Commercial Distribution

  • 00643169149649 ()


  • Bone graft packing block

n/a - 00613994933423

TROUGH EX0910177 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0910177
In Commercial Distribution

  • 00613994933423 ()


  • Bone graft packing block

n/a - 00613994933409

TROUGH EX0810836 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810836
In Commercial Distribution

  • 00613994933409 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994922175

HOLDER EX1210102 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210102
In Commercial Distribution

  • 00613994922175 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994922168

POSITIONER EX1110248 GRAFT GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
EX1110248
In Commercial Distribution

  • 00613994922168 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994963000

TROUGH EX1110104 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1110104
In Commercial Distribution

  • 00613994963000 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00643169293892

GUN EX1112020 GRAFT DELIVERY
MEDTRONIC SOFAMOR DANEK, INC.
EX1112020
In Commercial Distribution

  • 00643169293892 ()


  • Bone graft packing block

N/A - 00643169793934

STATION EX0516086 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0516086
In Commercial Distribution

  • 00643169793934 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00643169181526

POSITIONER EX0512197 LARGE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0512197
In Commercial Distribution

  • 00643169181526 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00643169190108

IMPACTOR EX0312181 GRAFT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX0312181
In Commercial Distribution

  • 00643169190108 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00643169021280

LOADING BLOCK EX0311357 PSR CAGE
MEDTRONIC SOFAMOR DANEK, INC.
EX0311357
In Commercial Distribution

  • 00643169021280 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00643169013285

HOLDER EX0411338 FACET GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0411338
In Commercial Distribution

  • 00643169013285 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00643169050709

IMPACTOR EX0711465 ANGLED GRAFT W/ TAB
MEDTRONIC SOFAMOR DANEK, INC.
EX0711465
In Commercial Distribution

  • 00643169050709 ()


  • Bone graft packing block

N/A - 00643169572645

LID 7426010 PACKING FIXTURE
MEDTRONIC SOFAMOR DANEK, INC.
7426010
In Commercial Distribution

  • 00643169572645 ()


  • Bone graft packing block

N/A - 00643169572638

FIXTURE 7426009 IMPLANT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
7426009
In Commercial Distribution

  • 00643169572638 ()


  • Bone graft packing block

Asfora Anterior Cervical Plate System - M364111106FD4940

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

Asfora Anterior Cervical Plate System - M364111106FD4860

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

Asfora Anterior Cervical Plate System - M364111106FD4740

4 Level, 74mm 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-FD4-74
In Commercial Distribution

  • 111106474 ()
  • M364111106FD4740 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD3750

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

Asfora Anterior Cervical Plate System - M364111106FD3660

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

Asfora Anterior Cervical Plate System - M364111106FD3600

3 Level, 60mm 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-FD3-60
In Commercial Distribution

  • 111106360 ()
  • M364111106FD3600 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD3570

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

Asfora Anterior Cervical Plate System - M364111106FD3540

3 Level, 54mm 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-FD3-54
In Commercial Distribution

  • 111106354 ()
  • M364111106FD3540 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD3510

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

Asfora Anterior Cervical Plate System - M364111106FD2500

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

Asfora Anterior Cervical Plate System - M364111106FD2470

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

Asfora Anterior Cervical Plate System - M364111106FD2410

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

Asfora Anterior Cervical Plate System - M364111106FD2380

2 Level, 38mm 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-FD2-38
In Commercial Distribution

  • 111106238 ()
  • M364111106FD2380 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD2350

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

Asfora Anterior Cervical Plate System - M364111106FD2320

2 Level, 32mm 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-FD2-32
In Commercial Distribution

  • 111106232 ()
  • M364111106FD2320 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD1340

1 Level, 34mm 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-FD1-34
In Commercial Distribution

  • 111106134 ()
  • M364111106FD1340 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD1320

1 Level, 32mm 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-FD1-32
In Commercial Distribution

  • 111106132 ()
  • M364111106FD1320 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD1300

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

Asfora Anterior Cervical Plate System - M364111106FD1280

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

Asfora Anterior Cervical Plate System - M364111106FD1260

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

Asfora Anterior Cervical Plate System - M364111106FD1240

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

Asfora Anterior Cervical Plate System - M364111106FD1220

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

Asfora Anterior Cervical Plate System - M364111106FD1200

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

Asfora Anterior Cervical Plate System - M364111106FD4900

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

Asfora Anterior Cervical Plate System - M364111106FD4820

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
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