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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GUN PUSHER - LARGE 10"
SPINAL ELEMENTS, INC.
11377-005
In Commercial Distribution

  • 00840606125949 ()


  • Bone graft packing block
GUN PUSHER - LARGE 9"
SPINAL ELEMENTS, INC.
11377-004
In Commercial Distribution

  • 00840606125932 ()


  • Bone graft packing block
GUN PUSHER - LARGE 8"
SPINAL ELEMENTS, INC.
11377-003
In Commercial Distribution

  • 00840606125925 ()


  • Bone graft packing block
GUN PUSHER - LARGE 7"
SPINAL ELEMENTS, INC.
11377-002
In Commercial Distribution

  • 00840606125918 ()


  • Bone graft packing block
GUN PUSHER - LARGE 6"
SPINAL ELEMENTS, INC.
11377-001
In Commercial Distribution

  • 00840606125901 ()


  • Bone graft packing block
PACKER - SMALL
SPINAL ELEMENTS, INC.
11388-102
In Commercial Distribution

  • 00840606149631 ()


  • Bone graft packing block
LONG PACKER - SMALL
SPINAL ELEMENTS, INC.
11388-101
In Commercial Distribution

  • 00840606149624 ()


  • Bone graft packing block
LONG PACKER - LARGE
SPINAL ELEMENTS, INC.
11388-001
In Commercial Distribution

  • 00840606149617 ()


  • Bone graft packing block
GUN PUSHER - SMALL
SPINAL ELEMENTS, INC.
11387-001
In Commercial Distribution

  • 00840606149600 ()


  • Bone graft packing block
GRAFT LOADING TOOL
SPINAL ELEMENTS, INC.
11385-001
In Commercial Distribution

  • 00840606149587 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY POCKETED PUSHER 12”
SPINAL ELEMENTS, INC.
11377-307
In Commercial Distribution

  • 00840606149556 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY POCKETED PUSHER 11”
SPINAL ELEMENTS, INC.
11377-306
In Commercial Distribution

  • 00840606149549 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY POCKETED PUSHER 9”
SPINAL ELEMENTS, INC.
11377-304
In Commercial Distribution

  • 00840606149532 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY POCKETED PUSHER 8”
SPINAL ELEMENTS, INC.
11377-303
In Commercial Distribution

  • 00840606149525 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY POCKETED PUSHER 7”
SPINAL ELEMENTS, INC.
11377-302
In Commercial Distribution

  • 00840606149518 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY POCKETED PUSHER 6”
SPINAL ELEMENTS, INC.
11377-301
In Commercial Distribution

  • 00840606149501 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY PUSHER SMALL 12”
SPINAL ELEMENTS, INC.
11377-106
In Commercial Distribution

  • 00840606149495 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY PUSHER SMALL 11”
SPINAL ELEMENTS, INC.
11377-106
In Commercial Distribution

  • 00840606149488 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY PUSHER SMALL 9”
SPINAL ELEMENTS, INC.
11377-104
In Commercial Distribution

  • 00840606149471 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY PUSHER SMALL 8”
SPINAL ELEMENTS, INC.
11377-103
In Commercial Distribution

  • 00840606149464 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY PUSHER SMALL 7”
SPINAL ELEMENTS, INC.
11377-102
In Commercial Distribution

  • 00840606149457 ()


  • Bone graft packing block
BONE GRAFT DELIVERY GUN BONE GRAFT DELIVERY PUSHER SMALL 6”
SPINAL ELEMENTS, INC.
11377-101
In Commercial Distribution

  • 00840606149440 ()


  • Bone graft packing block
BENGAL STACKABLE CAGE SYSTEM CAGE FILLER BLOCK
DEPUY SPINE, LLC
277308000
In Commercial Distribution

  • 10705034197692 ()
277308000

  • Bone graft packing block
BENGAL SYSTEM BONE FILLER BLOCK, EXTRA LARGE
DEPUY SPINE, LLC
273310301
In Commercial Distribution

  • 10705034188065 ()
273310301

  • Bone graft packing block
BENGAL SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
273310300
In Commercial Distribution

  • 10705034188058 ()
273310300

  • Bone graft packing block
No Description
Avery Biomedical Devices Inc
Neurostimulator Electrode Implant
In Commercial Distribution

  • 00850252006028 ()
E377-05

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Avery Biomedical Devices Inc
Neurostimulator Receiver Implant
In Commercial Distribution

  • 00850252006011 ()
I-110A

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 4
In Commercial Distribution

  • 07290114060899 ()
750-000027-00

  • Depth electrode
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
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