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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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Quantum - 90810005669170

4.25mm dia.12mm long variable screw Implant. The Quantum 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.
PCP-425-12V
In Commercial Distribution

  • 90810005669170 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • Intervertebral-body internal spinal fixation system

Quantum - 90810005669125

3.75mm dia.14mm long variable screw Implant. The Quantum 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.
PCP-375-14V
In Commercial Distribution

  • 90810005669125 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 14 Millimeter


  • Intervertebral-body internal spinal fixation system

Quantum - 90810005669064

4.25mm dia.14mm long fixed screw Implant. The Quantum 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.
PCP-425-14F
In Commercial Distribution

  • 90810005669064 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 14 Millimeter


  • Intervertebral-body internal spinal fixation system

Quantum - 90810005669057

4.25mm dia.12mm long fixed screw Implant. The Quantum 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.
PCP-425-12F
In Commercial Distribution

  • 90810005669057 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • Intervertebral-body internal spinal fixation system

PMT® CORPORATION - SPHENOIDAL - 10650551092992

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09-NS
In Commercial Distribution

  • 10650551092992 ()
  • 00650551092995 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-09-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092961

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05-NS
In Commercial Distribution

  • 10650551092961 ()
  • 00650551092964 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-05-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092954

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03-NS
In Commercial Distribution

  • 10650551092954 ()
  • 00650551092957 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-32-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092930

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03-NS
In Commercial Distribution

  • 10650551092930 ()
  • 00650551092933 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-31-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092916

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03-NS
In Commercial Distribution

  • 10650551092916 ()
  • 00650551092919 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-32-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092893

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03-NS
In Commercial Distribution

  • 10650551092893 ()
  • 00650551092896 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092879

SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122NS
In Commercial Distribution

  • 10650551092879 ()
  • 00650551092872 ()
2122NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092988

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-07-NS
In Commercial Distribution

  • 00650551092988 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.03125 Inch
2102-32-07-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092971

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-06-NS
In Commercial Distribution

  • 00650551092971 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-06-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092940

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-01-NS
In Commercial Distribution

  • 10650551092947 ()
  • 00650551092940 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-32-01-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092926

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2102-31-01-NS
In Commercial Distribution

  • 10650551092923 ()
  • 00650551092926 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-31-01-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092902

STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-01-NS
In Commercial Distribution

  • 10650551092909 ()
  • 00650551092902 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-01-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092889

STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2101-31-01-NS
In Commercial Distribution

  • 10650551092886 ()
  • 00650551092889 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-31-01-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092797

CRIMPING TOOL FOR NON-CRIMPED SPHENOIDAL ELECTRODE
PMT CORPORATION
2105
In Commercial Distribution

  • 00650551092797 ()
2105

  • Depth electrode

PLIF - 10705034186870

PLIF SG INSTRUMENTS CAGE FILLER BLOCK
DEPUY SPINE, LLC
273126001
Not in Commercial Distribution

  • 10705034186870 ()
273126001

  • Bone graft packing block

PERLA ® TL MIS - 07640450867872

MODULAR SCREW BASE
SpineArt SA
MPF-IN 33 00-N
In Commercial Distribution

  • 07640450867872 ()
MPF-IN 33 00-N

  • Bone graft packing block

PERLA TL - 07640375236173

CURVED TAMP
SpineArt SA
SPE-US 01 42-N
In Commercial Distribution

  • 07640375236173 ()
SPE-US 01 42-N

  • Bone graft packing block

Orthopaedic & Spine Development (OSD) - 03760178394857

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002-02
In Commercial Distribution

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394833

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394826

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394802

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394840

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002
In Commercial Distribution

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit

Origin Trial Neck - 09348215039813

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-022
In Commercial Distribution

  • 09348215039813 ()


  • Surgical implant template, reusable

Origin Trial Neck - 09348215039806

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-021
In Commercial Distribution

  • 09348215039806 ()


  • Surgical implant template, reusable

Origin Trial Neck - 09348215039790

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-020
In Commercial Distribution

  • 09348215039790 ()


  • Surgical implant template, reusable

Origin Stem Size 9 Template - 09348215055882

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable

Origin Stem Size 8 Template - 09348215055875

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-158
In Commercial Distribution

  • 09348215055875 ()


  • Surgical implant template, reusable

Origin Stem Size 20 Template - 09348215055974

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • Surgical implant template, reusable

Origin Stem Size 18 Template - 09348215055967

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


  • Surgical implant template, reusable

Origin Stem Size 16 Template - 09348215055950

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-166
In Commercial Distribution

  • 09348215055950 ()


  • Surgical implant template, reusable

Origin Stem Size 15 Template - 09348215055943

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-165
In Commercial Distribution

  • 09348215055943 ()


  • Surgical implant template, reusable

Origin Stem Size 14 Template - 09348215055936

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-164
In Commercial Distribution

  • 09348215055936 ()


  • Surgical implant template, reusable

Origin Stem Size 13 Template - 09348215055929

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-163
In Commercial Distribution

  • 09348215055929 ()


  • Surgical implant template, reusable

Origin Stem Size 12 Template - 09348215055912

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-162
In Commercial Distribution

  • 09348215055912 ()


  • Surgical implant template, reusable

Origin Stem Size 11 Template - 09348215055905

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-161
In Commercial Distribution

  • 09348215055905 ()


  • Surgical implant template, reusable

Origin Stem Size 10 Template - 09348215055899

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-160
In Commercial Distribution

  • 09348215055899 ()


  • Surgical implant template, reusable

Origin Starter Broach (Chilly Pepper) - 09348215055356

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
101-139
In Commercial Distribution

  • 09348215055356 ()


  • Orthopaedic broach

Origin Short Trial Neck - 09348215081416

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-026
In Commercial Distribution

  • 09348215081416 ()


  • Surgical implant template, reusable

Origin Short 125deg Trial Neck - 09348215081423

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087449

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5016
In Commercial Distribution

  • 09348215087449 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087432

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5015
In Commercial Distribution

  • 09348215087432 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087425

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5014
In Commercial Distribution

  • 09348215087425 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087418

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5013
In Commercial Distribution

  • 09348215087418 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087401

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7050
In Commercial Distribution

  • 09348215087401 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087395

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7040
In Commercial Distribution

  • 09348215087395 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087388

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7030
In Commercial Distribution

  • 09348215087388 ()


  • Surgical implant template, reusable
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