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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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


  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
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


  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
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

  • Intervertebral-body internal spinal fixation system
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-171-NS
In Commercial Distribution

  • 00650551148739 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-170-NS
In Commercial Distribution

  • 00650551148722 ()


  • Depth electrode
PLATINUM sEEG ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-169-NS
In Commercial Distribution

  • 00650551148715 ()


  • Depth electrode
PACKING STATION EX0818003 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0818003
In Commercial Distribution

  • 00763000216948 ()


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

  • 00763000371777 ()


  • Bone graft packing block
TROUGH EX0910177 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0910177
In Commercial Distribution

  • 00613994933423 ()


  • Bone graft packing block
TROUGH EX0810836 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810836
In Commercial Distribution

  • 00613994933409 ()


  • Bone graft packing block
microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm
FHC, INC.
KTF1001-00757
In Commercial Distribution

  • 00873263007570 ()
KTF1001

  • Depth electrode
  • Patient surgical drape, single-use
  • Intracerebral cannula, nonimplantable, single-use
microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm
FHC, INC.
KTF1001-00133
Not in Commercial Distribution

  • 00873263001332 ()
KTF1001

  • Patient surgical drape, single-use
  • Intracerebral cannula, implantable
  • Depth electrode
microTargeting Platform Procedure Consumables Kit, 1x, sterile, for use with mT or STar Drive, mT Platform and Guideline 4000 LP+. Contains: 44975L: D.ZAP Tungsten Differential Electrode - - 220.72mm electrode length, 10mm differential, 205.72mm protective tube length, DZAP(L) 1Meg, 0.55mm od. 66-DA-SD: Sterile Drape Sleeve for motor 66-EL-LP: Patient Lead for Guideline 4000 LP+ 66-IT-03P: Sterile Single Insertion Tube Set - IT(MP1) - 184.1mm tube length, 1.83mm od, 1.6mm id with Stylet PT(MP1) - Diameter reduction tube 0.58mm id
FHC, INC.
KT-PPK-S-00366
In Commercial Distribution

  • 00873263003664 ()
KT-PPK-S

  • Depth electrode
  • Patient surgical drape, single-use
  • Intracerebral cannula, implantable
microTargeting LP+ Patient Lead, Sterile, for use with microTargting Electrodes
FHC, INC.
66-EL-LP-00258
In Commercial Distribution

  • 00873263002582 ()
66-EL-LP

  • Depth electrode
microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00129
Not in Commercial Distribution

  • 10873263001292 ()
  • 00873263001295 ()

  • Length: 227.2 Millimeter
  • Length: 242.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
FC2004

  • Depth electrode
microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00117
Not in Commercial Distribution

  • 10873263001179 ()
  • 00873263001172 ()

  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
FC5000

  • Depth electrode
microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00755
In Commercial Distribution

  • 10873263007553 ()
  • 00873263007556 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 249.2 Millimeter
FC5000

  • Depth electrode
microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00752
In Commercial Distribution

  • 10873263007522 ()
  • 00873263007525 ()

  • Length: 227.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2004

  • Depth electrode
microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame and STar Drive. Contains: IT(AR16): Insertion Tube. IT(AR17): Insertion Tube w/ Stylet. MTDWLN(AR)(AR2): microTargeting Electrode. 66-CN-ET: Insertion Tube Extractor. Individual Specifications: IT(AR16) - 135mm tube length, 1.981mm OD, 0.96mm ID. IT(AR17) - 243.5mm tube length, 0.902mm OD, 0.597mm ID, 264mm stylet length (includes collar). MTDWLN(AR)(AR2) - 276.5mm electrode length, 10mm differential, 261.5mm protective tube length, 0.55mm OD. DZAP(L) 1 Meg
FHC, INC.
KTF1002-00134
Not in Commercial Distribution

  • 10873263001346 ()
  • 00873263001349 ()
KTF1002

  • Intracerebral cannula, implantable
  • Depth electrode
Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od
FHC, INC.
FC7100-00132
Not in Commercial Distribution

  • 10873263001322 ()
  • 00873263001325 ()
FC7100

  • Intracerebral cannula, implantable
  • Depth electrode
microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive. Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode. 1x IT(DB3) Insertion tube with Stylet. 1x PT(DB5) Protective Tube. Individual Specifications: MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L) IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id
FHC, INC.
FC4001-00116
Not in Commercial Distribution

  • 10873263001162 ()
  • 00873263001165 ()
FC4001

  • Depth electrode
  • Intracerebral cannula, implantable
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