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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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tangis - 90814008023847

Anterior Cervical Plating System, 4.25mm dia. 20mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-425-20V
In Commercial Distribution

  • 90814008023847 ()

  • Height: 20 Millimeter
  • Width: 4.25 Millimeter
  • Depth: 4.25 Millimeter


  • Spinal bone screw, non-bioabsorbable

tangis - 90814008023809

Anterior Cervical Plating System, 4.75mm dia. 14mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-475-14V
In Commercial Distribution

  • 90814008023809 ()

  • Height: 14 Millimeter
  • Width: 4.75 Millimeter
  • Depth: 4.75 Millimeter
ACP-475-14V

  • Spinal bone screw, non-bioabsorbable

tangis - 90814008023748

Anterior Cervical Plating System, 4.25mm dia. 12mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-425-12V
In Commercial Distribution

  • 90814008023748 ()

  • Height: 12 Millimeter
  • Width: 4.25 Millimeter
  • Depth: 4.25 Millimeter
ACP-425-12V

  • Spinal fixation plate, non-bioabsorbable

tangis - 90814008023489

Anterior Cervical Plating System, 4 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-4-68
In Commercial Distribution

  • 90814008023489 ()

  • Height: 68 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-4-68

  • Spinal fixation plate, non-bioabsorbable

tangis - 90814008023441

Anterior Cervical Plating System, 3 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-3-74
In Commercial Distribution

  • 90814008023441 ()

  • Height: 74 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-3-74

  • Spinal fixation plate, non-bioabsorbable

tangis - 90814008023403

Anterior Cervical Plating System, 3 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-3-62
In Commercial Distribution

  • 90814008023403 ()

  • Height: 62 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-3-62

  • Spinal fixation plate, non-bioabsorbable

tangis - 90814008023359

Anterior Cervical Plating System, 2 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-2-51
In Commercial Distribution

  • 90814008023359 ()

  • Height: 51 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter


  • Spinal fixation plate, non-bioabsorbable

tangis - 90814008023298

Anterior Cervical Plating System, 2 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-2-33
In Commercial Distribution

  • 90814008023298 ()

  • Height: 33 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-2-33

  • Spinal fixation plate, non-bioabsorbable

tangis - 90814008023281

Anterior Cervical Plating System, 1 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-1-34
In Commercial Distribution

  • 90814008023281 ()

  • Height: 34 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-1-34

  • Spinal fixation plate, non-bioabsorbable

tangis - 90814008023625

Anterior Cervical Plating System, 4.25mm dia. 12mm long fixed screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-425-12F
In Commercial Distribution

  • 90814008023625 ()

  • Height: 12 Millimeter
  • Width: 4.25 Millimeter
  • Depth: 4.25 Millimeter
ACP-425-12F

  • Spinal bone screw, non-bioabsorbable

tangis - 90814008023564

Anterior Cervical Plating System, 3.75mm dia. 12mm long fixed screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-375-12F
In Commercial Distribution

  • 90814008023564 ()

  • Height: 12 Millimeter
  • Width: 3.75 Millimeter
  • Depth: 3.75 Millimeter
ACP-375-12F

  • Spinal bone screw, non-bioabsorbable

tangis - 90814008023519

Anterior Cervical Plating System, 4 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-4-80
In Commercial Distribution

  • 90814008023519 ()

  • Height: 80 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-4-80

  • Spinal fixation plate, non-bioabsorbable

sEEG Depthalon - 00650551147343

sEEG Depthalon Electrode, 16 macro contacts mini connector, 1 exit, 1, lead, 1 tail
PMT CORPORATION
2102-16-166
In Commercial Distribution

  • 00650551147343 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551141280

sEEG, PLATINUM, 16 CONTACT, 2MM CONTACT, MINI CONNECTOR, REMOVABLE STYLET,
PMT CORPORATION
2102-16-133
In Commercial Distribution

  • 00650551141280 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551005070

SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, 45MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, NON-STERILE
PMT CORPORATION
2102-16-180-NS
In Commercial Distribution

  • 00650551005070 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551005018

SEEG, 8 CONTACT, 2MM CONTACT, 26.5MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK, NON-STERILE
PMT CORPORATION
2102-08-189-NS
In Commercial Distribution

  • 00650551005018 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004936

SEEG DEPTH ELECTRODE, 16 CONTACT, 17.8mm RECORDING LENGTH, 2mm BULLET TIP, 0.5 PLATINUM CONTACTS, NO CONN, REMOVABLE STYLET, NON-STERILE
PMT CORPORATION
2102-16-188-NS
In Commercial Distribution

  • 00650551004936 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004899

SEEG DEPTH ELECTRODE, 16 CONTACT, 17.8mm RECORDING LENGTH, 2mm BULLET TIP, 0.5 PLATINUM CONTACTS, NO CONN, REMOVABLE STYL
PMT CORPORATION
2102-16-188
In Commercial Distribution

  • 00650551004899 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004844

SEEG, 8 CONTACT, 2MM CONTACT, 26.5MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK
PMT CORPORATION
2102-08-189
In Commercial Distribution

  • 00650551004844 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004837

PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, 0.8MM OD, 2MM CONTACT LENGTH, 100MM RECORDING DEPTH,
PMT CORPORATION
2102-16-192
In Commercial Distribution

  • 00650551004837 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004820

PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, 0.8MM OD, 2MM CONTACT LENGTH, 90MM RECORDING DEPTH,
PMT CORPORATION
2102-16-191
In Commercial Distribution

  • 00650551004820 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004813

PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, 0.8MM OD, 2MM CONTACT LENGTH, 80MM RECORDING DEPTH,
PMT CORPORATION
2102-16-190
In Commercial Distribution

  • 00650551004813 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004141

SEEG, 16 CONTACT, 2MM CONTACT, 77MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK
PMT CORPORATION
2102-16-187
In Commercial Distribution

  • 00650551004141 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004134

SEEG, 14 CONTACT, 2MM CONTACT, 67MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK
PMT CORPORATION
2102-14-187
In Commercial Distribution

  • 00650551004134 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004127

SEEG, 12 CONTACT, 2MM CONTACT, 57MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK
PMT CORPORATION
2102-12-187
In Commercial Distribution

  • 00650551004127 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004110

SEEG, 10 CONTACT, 2MM CONTACT, 47MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK
PMT CORPORATION
2102-10-187
In Commercial Distribution

  • 00650551004110 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004103

SEEG, 8 CONTACT, 2MM CONTACT, 37MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK
PMT CORPORATION
2102-08-187
In Commercial Distribution

  • 00650551004103 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004097

SEEG, 6 CONTACT, 2MM CONTACT, 27MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK
PMT CORPORATION
2102-06-187
In Commercial Distribution

  • 00650551004097 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004080

SEEG, 4 CONTACT, 2MM CONTACT, 17MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK
PMT CORPORATION
2102-04-187
In Commercial Distribution

  • 00650551004080 ()


  • Depth electrode

sEEG DEPTHALON® - 00650551004011

SEEG, 16 CONTACT, 2MM CONTACT SIZE, 55CM LENGTH, REMOVABLE STYLET
PMT CORPORATION
2102-16-132
In Commercial Distribution

  • 00650551004011 ()


  • Depth electrode
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