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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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Xsert Lumbar Expandable Interbody System - M697X092091024STR1

9mm-13mm x 10mm x 24mm PLIF ASSY (STERILE)
Xtant Medical Holdings, Inc.
X092-091024-STR
In Commercial Distribution

  • M697X092091024STR0 ()
  • M697X092091024STR1 ()

  • Height 9-13 mm
  • Length: 24 Millimeter
  • Width: 10 Millimeter


  • Metallic spinal interbody fusion cage

Xsert Lumbar Expandable Interbody System - M697X0920910245STR1

9mm-13mm x 10mm x 24mm x 5° PLIF ASSY (STERILE)
Xtant Medical Holdings, Inc.
X092-091024-5-STR
In Commercial Distribution

  • M697X0920910245STR0 ()
  • M697X0920910245STR1 ()

  • Angle: 5 degree
  • Width: 10 Millimeter
  • Length: 24 Millimeter
  • Height 9-13 mm


  • Metallic spinal interbody fusion cage

Aranax Anterior Cervical Plating System - M697X0861618STSTR1

Ø4.00 FIXED SELF-TAPPING SCREW, 18 mm
Xtant Medical Holdings, Inc.
X086-1618ST-STR
In Commercial Distribution

  • M697X0861618STSTR1 ()
  • M697X0861618STSTR0 ()

  • Outer Diameter: 4 Millimeter
  • Length: 18 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Aranax Anterior Cervical Plating System - M697X0861616SDSTR1

Ø4.00 FIXED SELF-DRILLING SCREW, 16 mm
Xtant Medical Holdings, Inc.
X086-1616SD-STR
In Commercial Distribution

  • M697X0861616SDSTR1 ()
  • M697X0861616SDSTR0 ()

  • Outer Diameter: 4 Millimeter
  • Length: 16 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Aranax Anterior Cervical Plating System - M697X08600061

STERILIZATION CADDY, 4-LEVEL TEMPLATES
Xtant Medical Holdings, Inc.
X086-0006
In Commercial Distribution

  • M697X08600060 ()
  • M697X08600061 ()


  • Spinal fixation plate, non-bioabsorbable

Aranax Anterior Cervical Plating System - M697X08600051

STERILIZATION CADDY, PINS/TEMPLATES
Xtant Medical Holdings, Inc.
X086-0005
In Commercial Distribution

  • M697X08600050 ()
  • M697X08600051 ()


  • Spinal fixation plate, non-bioabsorbable

Aranax Anterior Cervical Plating System - M697X08600041

STERILIZATION CASE, PRIMARY, ARANAX
Xtant Medical Holdings, Inc.
X086-0004
In Commercial Distribution

  • M697X08600040 ()
  • M697X08600041 ()


  • Spinal fixation plate, non-bioabsorbable

Excella® - M711EP00014

No Description
Innovasis, Inc.
EP0001
In Commercial Distribution

  • M711EP00014 ()
  • M711EP00011 ()
EP0001

  • Spinal bone screw, non-bioabsorbable

Evolution - M684EIC8S17R1

EVOLUTION® MP™ CR INSERT SIZE 8 STANDARD 17MM RIGHT
Microport Orthopedics Inc.
EIC8S17R
In Commercial Distribution

  • EIC8S17R ()
  • M684EIC8S17R1 ()

  • Height: 17 Millimeter
EIC8S17R

  • Tibial insert

Evolution - M684EIC8S17L1

EVOLUTION® MP™ CR INSERT SIZE 8 STANDARD 17MM LEFT
Microport Orthopedics Inc.
EIC8S17L
In Commercial Distribution

  • EIC8S17L ()
  • M684EIC8S17L1 ()

  • Height: 17 Millimeter
EIC8S17L

  • Tibial insert
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