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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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The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device.
Providence Medical Technology, Inc.
PD-32-301
Not in Commercial Distribution

  • 10852776006024 ()
PD-32-301

  • Implantable cervical facet joint distractor
The DTRAX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Providence Medical Technology, Inc.
PD-31-100
Not in Commercial Distribution

  • 10852776006017 ()
PD-31-100

  • Implantable cervical facet joint distractor
The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Providence Medical Technology, Inc.
PD-31-200
Not in Commercial Distribution

  • 10852776006000 ()
PD-31-200

  • Implantable cervical facet joint distractor
DISTRACTOR, JOINT/OSTEOTOMY
MEDLINE INDUSTRIES, INC.
MPX00001
In Commercial Distribution

  • 10888277365841 ()
MPX00001

  • Implantable cervical facet joint distractor
The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Providence Medical Technology, Inc.
PD-31-200
Not in Commercial Distribution

  • 20852776006069 ()


  • Implantable cervical facet joint distractor
The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device.
Providence Medical Technology, Inc.
PD-32-301
Not in Commercial Distribution

  • 20852776006021 ()


  • Implantable cervical facet joint distractor
Hand Tool #32A Driver for 4.0mm angled one piece Implant (CBA)
Suncoast Dental, Inc
Hand Tool / HT.32A
In Commercial Distribution

  • 00083208320040 ()

  • Hand Tool #32A Driver for 4.0mm angled one piece Implant (CBA)
HT.32A

  • Dental implant system
Hand Tool #31A Driver for 3.5mm angled one piece Implant (CBA)
Suncoast Dental, Inc
Hand Tool / HT.31A
In Commercial Distribution

  • 00083208310041 ()

  • Hand Tool #31A Driver for 3.5mm angled one piece Implant (CBA)
HT.31A

  • Dental implant system
Hand Tool #13 Driver for 3.0mm angled one piece Implant (CBA)
Suncoast Dental, Inc
Hand Tool / HT.13
In Commercial Distribution

  • 00083208130045 ()

  • Hand Tool #13 Driver for 3.0mm angled one piece Implant (CBA)
HT.13

  • Dental implant system
Abutment/6.0 to 8.0 Blank straight post for Integrity 6.0-8.0 Implants
Suncoast Dental, Inc
Abutment/6.0 to 8.0 Blank straight post for Integrity 6.0-8.0 Implants
Not in Commercial Distribution

  • 00083208960802 ()

  • Height: 10 Millimeter
  • Abutment/6.0 to 8.0 Blank straight post for Integrity 6.0-8.0 Implants
  • Outer Diameter: 9.5 Millimeter
PITI6.0-8.0 Blank

  • Screw endosteal dental implant, two-piece
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