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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CrossLink, Large 58-74mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-2000-5874
In Commercial Distribution

  • 00814008027606 ()


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Straight 5.5X240mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
S-01-240
In Commercial Distribution

  • 00814008027569 ()

  • Length: 240 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Straight 5.5X120mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
S-01-120
In Commercial Distribution

  • 00814008027545 ()

  • Length: 120 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Straight 5.5X80mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
S-01-080
In Commercial Distribution

  • 00814008027514 ()

  • Length: 80 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 5.5X95mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion5
NVISION BIOMEDICAL TECHNOLOGIES, INC.
L-01-095
In Commercial Distribution

  • 00810005667241 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 95 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
EVOL®ha-C Cervical Bone Packing Block
Cutting Edge Spine, LLC
CES-472
In Commercial Distribution

  • 00841193121246 ()

  • Length: 50 Millimeter
CES-472

  • Bone graft packing block
Graft Packing & Screw Reference Block
TITAN SPINE, LLC
5210-1017
Not in Commercial Distribution

  • 00191375028345 ()

  • Height: 1 Inch
  • Width: 2 Inch
  • Length: 1.5 Inch
5210-1017

  • Bone graft packing block
Graft Packing & Screw Reference Block
TITAN SPINE, LLC
2300-1317
Not in Commercial Distribution

  • 00191375028338 ()

  • Width: 1.5 Inch
  • Length: 2 Inch
  • Height: 1.25 Inch
2300-1317

  • Bone graft packing block
EARP, 14X25X08 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP1425-0008
In Commercial Distribution

  • 00810135960007 ()

  • Depth: 14 Millimeter
  • Width: 25 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Drive Headstage
In Commercial Distribution

  • 07290114061520 ()
700-006000-00

  • Depth electrode
Depthalon Electrode, Platinum, Non-sterile, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Inline connector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-003-NS
In Commercial Distribution

  • 00650551144403 ()


  • Depth electrode
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution

  • 09348215058098 ()


  • Instrument tray, reusable
MICROWIRE DEPTHALON ELECTRODE, 57 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-07-57-001-NS
In Commercial Distribution

  • 00650551143888 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 20 Centimeter
  • Contact Size 1.5 Millimeter
2104-07-57-001-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 48 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-07-48-001-NS
In Commercial Distribution

  • 00650551143727 ()

  • Microwire Diameter 25 Micrometer
  • Main Tube Length 20 Centimeter
  • Contact Size 5 Millimeter
2104-07-48-001-NS

  • Depth electrode
sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-12-145-NS
In Commercial Distribution

  • 00650551143208 ()

  • Main Tube Length 27 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 57 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-12-145-NS

  • Depth electrode
sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-14-145-NS
In Commercial Distribution

  • 00650551143192 ()

  • Main Tube Length 27 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 67 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-14-145-NS

  • Depth electrode
sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-111-NS
In Commercial Distribution

  • 00650551142843 ()

  • Main Tube Length 27 Centimeter
  • Spacing 0.9 Millimeter
  • Recording Depth 16.7 Millimeter
  • Contact Length 1.3 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-111-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 48 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-16-48-002-NS
In Commercial Distribution

  • 00650551142805 ()

  • Microwire Diameter 25 Micrometer
  • Main Tube Length 9 Centimeter
  • Contact Size 0.5 Millimeter
2104-16-48-002-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 10 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-00-10-002-NS
In Commercial Distribution

  • 00650551142652 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 22.5 Centimeter
2104-00-10-002-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, NON-STANDARD CONNECTOR
PMT CORPORATION
2102-04-002-NS
In Commercial Distribution

  • 00650551142638 ()

  • Main Tube Length 22 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
  • Contact Length 2 Millimeter
2102-04-002-NS

  • Depth electrode
sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-291-NS
In Commercial Distribution

  • 00650551142485 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 33.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-291-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL, 27.25MM SPACING BETWEEN CONTACTS #8 & #9
PMT CORPORATION
2102-16-134-NS
In Commercial Distribution

  • 00650551142461 ()

  • Main Tube Length 55 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-134-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-157-NS
In Commercial Distribution

  • 00650551142133 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 85 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-157-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, MINI CONNECTOR
PMT CORPORATION
2102-04-101-NS
In Commercial Distribution

  • 00650551141655 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 12.5 Millimeter
  • Contact Length 2 Millimeter
2102-04-101-NS

  • Depth electrode
sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-144-NS
In Commercial Distribution

  • 00650551139829 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1 Millimeter
  • Recording Depth 29 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-144-NS

  • Depth electrode
sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-145-NS
In Commercial Distribution

  • 00650551139812 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 37 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-145-NS

  • Depth electrode
sEEG, PLATINUM, 6 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-06-145-NS
In Commercial Distribution

  • 00650551139720 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 27 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-06-145-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-112-NS
In Commercial Distribution

  • 00650551137504 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.37 Millimeter
  • Recording Depth 41.3 Millimeter
  • Contact Length 1.3 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-112-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 36MM SPACING BETWEEN CONTACTS #13 & #14
PMT CORPORATION
2102-16-154-NS
In Commercial Distribution

  • 00650551131496 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 110 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-154-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 21MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-153-NS
In Commercial Distribution

  • 00650551131489 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 95 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-153-NS

  • Depth electrode
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