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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HA PEEK, Ta
Innovasis, Inc.
LXL18104512
In Commercial Distribution

  • M711LXL181045121 ()
  • M711LXL181045120 ()

  • Width: 18 Millimeter
  • Height: 10 Millimeter
  • Length: 45 Millimeter
  • Angle: 12 degree
LXL18104512

  • Polymeric spinal fusion cage, sterile
HA PEEK, Ta
Innovasis, Inc.
CH141709
In Commercial Distribution

  • M711CH1417091 ()
  • M711CH1417090 ()

  • Angle: 8 degree
  • Height: 9 Millimeter
  • Width: 17 Millimeter
  • Length: 14 Millimeter
CH141709

  • Polymeric spinal fusion cage, sterile
27mm x 12mm x 8mm Curved TLIF with Inserter and Tamp
XENCO MEDICAL LLC
XM-011-2708
In Commercial Distribution

  • B064XM01127081 ()
  • B064XM1000001 ()


  • Polymeric spinal fusion cage, sterile
Irix-A Modular Handle
Xtant Medical Holdings, Inc.
C080-0111
In Commercial Distribution

  • M697C08001110 ()
  • M697C08001111 ()


  • Polymeric spinal fusion cage, sterile
Universal Joint Drill
Xtant Medical Holdings, Inc.
C080-0110
In Commercial Distribution

  • M697C08001100 ()
  • M697C08001101 ()


  • Polymeric spinal fusion cage, sterile
Straight Drill
Xtant Medical Holdings, Inc.
C080-0109
In Commercial Distribution

  • M697C08001090 ()
  • M697C08001091 ()


  • Polymeric spinal fusion cage, sterile
Irix-A Smooth shaft Universal Joint Driver
Xtant Medical Holdings, Inc.
C080-0108
In Commercial Distribution

  • M697C08001080 ()
  • M697C08001081 ()


  • Polymeric spinal fusion cage, sterile
Irix-A Smooth Driver
Xtant Medical Holdings, Inc.
C080-0107
In Commercial Distribution

  • M697C08001070 ()
  • M697C08001071 ()


  • Polymeric spinal fusion cage, sterile
Specialty Irix A Fixed Angle Guided AWL Assembly
Xtant Medical Holdings, Inc.
C080-0102
In Commercial Distribution

  • M697C08001020 ()
  • M697C08001021 ()


  • Polymeric spinal fusion cage, sterile
Specialty ALIF Distractor
Xtant Medical Holdings, Inc.
C080-0078
In Commercial Distribution

  • M697C08000780 ()
  • M697C08000781 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY UNIVERSAL JOINT AWL (STIFFER JOINT)
Xtant Medical Holdings, Inc.
C080-0070
In Commercial Distribution

  • M697C08000700 ()
  • M697C08000701 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 42X30X12 DEG 19mm
Xtant Medical Holdings, Inc.
C080-0069
In Commercial Distribution

  • M697C08000690 ()
  • M697C08000691 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 42X30X12 DEG 17mm
Xtant Medical Holdings, Inc.
C080-0068
In Commercial Distribution

  • M697C08000680 ()
  • M697C08000681 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 42X30X12 DEG 15mm
Xtant Medical Holdings, Inc.
C080-0067
In Commercial Distribution

  • M697C08000670 ()
  • M697C08000671 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 42X30X12 DEG 13mm
Xtant Medical Holdings, Inc.
C080-0066
In Commercial Distribution

  • M697C08000660 ()
  • M697C08000661 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 42X30X12 DEG 11mm
Xtant Medical Holdings, Inc.
C080-0065
In Commercial Distribution

  • M697C08000650 ()
  • M697C08000651 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 38X28X12 DEG 19mm
Xtant Medical Holdings, Inc.
C080-0059
In Commercial Distribution

  • M697C08000590 ()
  • M697C08000591 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 38X28X12 DEG 17mm
Xtant Medical Holdings, Inc.
C080-0058
In Commercial Distribution

  • M697C08000580 ()
  • M697C08000581 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 38X28X12 DEG 15mm
Xtant Medical Holdings, Inc.
C080-0057
In Commercial Distribution

  • M697C08000570 ()
  • M697C08000571 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 38X28X12 DEG 13mm
Xtant Medical Holdings, Inc.
C080-0056
In Commercial Distribution

  • M697C08000560 ()
  • M697C08000561 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 38X28X12 DEG 11mm
Xtant Medical Holdings, Inc.
C080-0055
In Commercial Distribution

  • M697C08000550 ()
  • M697C08000551 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 33X26X12 DEG 19mm
Xtant Medical Holdings, Inc.
C080-0049
In Commercial Distribution

  • M697C08000490 ()
  • M697C08000491 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 33X26X12 DEG 17mm
Xtant Medical Holdings, Inc.
C080-0048
In Commercial Distribution

  • M697C08000480 ()
  • M697C08000481 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 33X26X12 DEG 15mm
Xtant Medical Holdings, Inc.
C080-0047
In Commercial Distribution

  • M697C08000470 ()
  • M697C08000471 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 33X26X12 DEG 13mm
Xtant Medical Holdings, Inc.
C080-0046
In Commercial Distribution

  • M697C08000460 ()
  • M697C08000461 ()


  • Polymeric spinal fusion cage, sterile
SPECIALTY IRIX A RASP ASSEMBLY 33X26X12 DEG 11mm
Xtant Medical Holdings, Inc.
C080-0045
In Commercial Distribution

  • M697C08000450 ()
  • M697C08000451 ()


  • Polymeric spinal fusion cage, sterile
19 MM SPECIALTY 42X30X12 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0038
In Commercial Distribution

  • M697C08000380 ()
  • M697C08000381 ()


  • Polymeric spinal fusion cage, sterile
17 MM SPECIALTY 42X30X12 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0037
In Commercial Distribution

  • M697C08000370 ()
  • M697C08000371 ()


  • Polymeric spinal fusion cage, sterile
15 MM SPECIALTY 42X30X12 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0036
In Commercial Distribution

  • M697C08000360 ()
  • M697C08000361 ()


  • Polymeric spinal fusion cage, sterile
13 MM SPECIALTY 42X30X12 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0035
In Commercial Distribution

  • M697C08000350 ()
  • M697C08000351 ()


  • Polymeric spinal fusion cage, sterile
11 MM SPECIALTY 42X30X12 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0034
In Commercial Distribution

  • M697C08000340 ()
  • M697C08000341 ()


  • Polymeric spinal fusion cage, sterile
19 MM SPECIALTY 42X30X8 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0033
In Commercial Distribution

  • M697C08000330 ()
  • M697C08000331 ()


  • Polymeric spinal fusion cage, sterile
17 MM SPECIALTY 42X30X8 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0032
In Commercial Distribution

  • M697C08000320 ()
  • M697C08000321 ()


  • Polymeric spinal fusion cage, sterile
15 MM SPECIALTY 42X30X8 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0031
In Commercial Distribution

  • M697C08000310 ()
  • M697C08000311 ()


  • Polymeric spinal fusion cage, sterile
13 MM SPECIALTY 42X30X8 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0030
In Commercial Distribution

  • M697C08000300 ()
  • M697C08000301 ()


  • Polymeric spinal fusion cage, sterile
11 MM SPECIALTY 42X30X8 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0029
In Commercial Distribution

  • M697C08000290 ()
  • M697C08000291 ()


  • Polymeric spinal fusion cage, sterile
19 MM SPECIALTY 38X28X12 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0028
In Commercial Distribution

  • M697C08000280 ()
  • M697C08000281 ()


  • Polymeric spinal fusion cage, sterile
17 MM SPECIALTY 38X28X12 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0027
In Commercial Distribution

  • M697C08000270 ()
  • M697C08000271 ()


  • Polymeric spinal fusion cage, sterile
15 MM SPECIALTY 38X28X12 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0026
In Commercial Distribution

  • M697C08000260 ()
  • M697C08000261 ()


  • Polymeric spinal fusion cage, sterile
13 MM SPECIALTY 38X28X12 DEG IRIX A MODULAR TRIAL HEAD
Xtant Medical Holdings, Inc.
C080-0025
In Commercial Distribution

  • M697C08000250 ()
  • M697C08000251 ()


  • Polymeric spinal fusion cage, sterile
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