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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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Irix-C Cervical Integrated Fusion System - M697C06601011

SPECIALTY 8MM IRIX-C GUIDED MODULAR INSERTER TIP W/O STOPS
Xtant Medical Holdings, Inc.
C066-0101
In Commercial Distribution

  • M697C06601010 ()
  • M697C06601011 ()

  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06600831

SPECIALTY 7/8 IRIX-C DOUBLE END 18X14 LORDOTIC TRIAL ASSY W/O STOPS
Xtant Medical Holdings, Inc.
C066-0083
In Commercial Distribution

  • M697C06600830 ()
  • M697C06600831 ()

  • Height: 8 Millimeter
  • Height: 7 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06600791

SPECIALTY 7/8 IRIX-C DOUBLE END 16X13 PARALLEL TRIAL ASSY W/O STOPS
Xtant Medical Holdings, Inc.
C066-0079
In Commercial Distribution

  • M697C06600790 ()
  • M697C06600791 ()

  • Height: 7 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06600751

SPECIALTY 7/8 IRIX-C DOUBLE END 16X13 LORDOTIC TRIAL ASSY W/O STOPS
Xtant Medical Holdings, Inc.
C066-0075
In Commercial Distribution

  • M697C06600750 ()
  • M697C06600751 ()

  • Height: 7 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion system - M697C06600421

7/8mm Double End 16 x 13 Lordotic Trial Assy
Xtant Medical Holdings, Inc.
C066-0042
In Commercial Distribution

  • M697C06600420 ()
  • M697C06600421 ()

  • Height: 8 Millimeter
  • Height: 7 Millimeter
  • Width: 16 Millimeter
  • Length: 13 Millimeter


  • Metallic spinal fusion cage, non-sterile

Calix Spinal Implant System - M697C03402081

8MM SPECIALTY PADDLE STYLE TRIAL ASSEMBLY
Xtant Medical Holdings, Inc.
C034-0208
In Commercial Distribution

  • M697C03402080 ()
  • M697C03402081 ()

  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697C03400151

8 MM, SPECIALTY PLIF LOLLIPOP RASP W/ TEE HANDLE ASSEMBLY.
Xtant Medical Holdings, Inc.
C034-0015
In Commercial Distribution

  • M697C03400150 ()
  • M697C03400151 ()

  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage

Calix-C Cervical Interbody Spacer - M697C00300531

Special 13mm x 16mm Lordotic Rasp, 8mm
Xtant Medical Holdings, Inc.
C003-0053
In Commercial Distribution

  • M697C00300530 ()
  • M697C00300531 ()

  • Width: 16 Millimeter
  • Length: 13 Millimeter
  • Height: 8 Millimeter
  • Angle: 7 degree


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06606931

8mm Parallel Rasp Assy, 16 X 13
Xtant Medical Holdings, Inc.
T066-0693
In Commercial Distribution

  • M697T06606930 ()
  • M697T06606931 ()

  • Width: 16 Millimeter
  • Length: 13 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06606621

7/8mm Parallel Trial Assy, 18 X 14
Xtant Medical Holdings, Inc.
T066-0662
In Commercial Distribution

  • M697T06606620 ()
  • M697T06606621 ()

  • Length: 14 Millimeter
  • Height: 7 Millimeter
  • Width: 18 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage
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