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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 - 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 - M697C06600111

CUSTOM FIXED ANGLE DRIVER
Xtant Medical Holdings, Inc.
C066-0011
In Commercial Distribution

  • M697C06600110 ()
  • M697C06600111 ()


  • 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 Lumbar Spinal Implant System - M697C03410001

ASSEMBLY, SPECIAL INSERTER
Xtant Medical Holdings, Inc.
C034-1000
In Commercial Distribution

  • M697C03410001 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697C03402531

Specialty 5mm angled Calix Lumbar rasp with fixed handle
Xtant Medical Holdings, Inc.
C034-0253
In Commercial Distribution

  • M697C03402530 ()
  • M697C03402531 ()


  • 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

Irix-A Lumbar Integrated Fusion System - M697C03402471

Specialty Irix A/Alif Inserter
Xtant Medical Holdings, Inc.
C034-0247
In Commercial Distribution

  • M697C03402470 ()
  • M697C03402471 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697C03402451

SPECIALTY ROTATING TLIF INSERTER ASSEMBLY
Xtant Medical Holdings, Inc.
C034-0245
In Commercial Distribution

  • M697C03402450 ()
  • M697C03402451 ()


  • Polymeric spinal interbody fusion cage
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