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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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Fortex Pedicle Screw System - M697X07704011

CoCr, Straight Rods, 5.5mm Dia Bar X 40mm
Xtant Medical Holdings, Inc.
X077-0401
In Commercial Distribution

  • M697X07704011 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697X07704001

CoCr, Straight Rods, 5.5mm Dia Bar X 35mm
Xtant Medical Holdings, Inc.
X077-0400
In Commercial Distribution

  • M697X07704001 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Zyfix Spinal Facet Screw System - M697X07600341

Zygafix COMPRESSION SCREW, 6.0 x 45MM SINGLE THREAD
Xtant Medical Holdings, Inc.
X076-0034
In Commercial Distribution

  • M697X07600341 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile

Zyfix Spinal Facet Screw System - M697X07600241

Zygafix COMPRESSION SCREW, 6.0 x 45MM DUAL THREAD
Xtant Medical Holdings, Inc.
X076-0024
In Commercial Distribution

  • M697X07600241 ()

  • Outer Diameter: 6 Millimeter
  • Length: 45 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile

Xpress Minimally Invasive Pedicle Screw System - M697X07382545DL1

XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 45mm
Xtant Medical Holdings, Inc.
X073-82545-DL
In Commercial Distribution

  • M697X07382545DL1 ()

  • Length: 45 Millimeter
  • Outer Diameter: 8.25 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Xpress Minimally Invasive Pedicle Screw System - M697X073825451

XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 45mm
Xtant Medical Holdings, Inc.
X073-82545
In Commercial Distribution

  • M697X073825451 ()

  • Outer Diameter: 8.25 Millimeter
  • Length: 45 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Xpress Minimally Invasive Pedicle Screw System - M697X0737545DL1

XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 45mm
Xtant Medical Holdings, Inc.
X073-7545-DL
In Commercial Distribution

  • M697X0737545DL1 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 45 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Xpress Minimally Invasive Pedicle Screw System - M697X07375451

XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 45mm
Xtant Medical Holdings, Inc.
X073-7545
In Commercial Distribution

  • M697X07375451 ()

  • Length: 45 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Xpress Minimally Invasive Pedicle Screw System - M697X0736545DL1

XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 6.5 x 45mm
Xtant Medical Holdings, Inc.
X073-6545-DL
In Commercial Distribution

  • M697X0736545DL1 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 45 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Xpress Minimally Invasive Pedicle Screw System - M697X07365451

XPRESS SYSTEM PEDICLE SCREW ASSY, 6.5 x 45mm
Xtant Medical Holdings, Inc.
X073-6545
In Commercial Distribution

  • M697X07365451 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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