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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 - M697C06601031

SPECIALTY 10MM IRIX-C GUIDED MODULAR INSERTER TIP W/O STOPS
Xtant Medical Holdings, Inc.
C066-0103
In Commercial Distribution

  • M697C06601030 ()
  • M697C06601031 ()

  • Height: 10 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06601021

SPECIALTY 9MM IRIX-C GUIDED MODULAR INSERTER TIP W/O STOPS
Xtant Medical Holdings, Inc.
C066-0102
In Commercial Distribution

  • M697C06601020 ()
  • M697C06601021 ()

  • Height: 9 Millimeter


  • Polymeric spinal interbody fusion cage

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 - M697C06600571

SPECIALTY SHORTENED IRIX-C INSERTER
Xtant Medical Holdings, Inc.
C066-0057
In Commercial Distribution

  • M697C06600570 ()
  • M697C06600571 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06600101

SPECIALTY ANGLED AWL
Xtant Medical Holdings, Inc.
C066-0010
In Commercial Distribution

  • M697C06600100 ()
  • M697C06600101 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697C03409611

Paddle Shaver, 17mm
Xtant Medical Holdings, Inc.
C034-0961
In Commercial Distribution

  • M697C03409610 ()
  • M697C03409611 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697C03402511

Specialty 5mm straight Calix Lumbar rasp w/fixed handle
Xtant Medical Holdings, Inc.
C034-0251
In Commercial Distribution

  • M697C03402510 ()
  • M697C03402511 ()


  • Polymeric spinal interbody fusion cage

Calix P - M697C03402491

Calix P Specialty Slap Hammer
Xtant Medical Holdings, Inc.
C034-0249
In Commercial Distribution

  • M697C03402490 ()
  • M697C03402491 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697C03402481

Specialty Short Stroke Slide Hammer Assembly
Xtant Medical Holdings, Inc.
C034-0248
In Commercial Distribution

  • M697C03402480 ()
  • M697C03402481 ()


  • Polymeric spinal interbody fusion cage
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