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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-A Specialty Irix-A Driver
Xtant Medical Holdings, Inc.
C080-0039
In Commercial Distribution

  • M697C08000390 ()
  • M697C08000391 ()


  • Surgical screwdriver, reusable
Specialty Xpress Cannulated Final Locking Cap Driver
Xtant Medical Holdings, Inc.
C073-0090
In Commercial Distribution

  • M697C07300900 ()
  • M697C07300901 ()


  • Surgical screwdriver, reusable
Xpress Specialty Shortended Interference Fit Head Turner
Xtant Medical Holdings, Inc.
C073-0089
In Commercial Distribution

  • M697C07300890 ()
  • M697C07300891 ()


  • Surgical screwdriver, reusable
Shortened Pedical Screw Head Turner
Xtant Medical Holdings, Inc.
C073-0087
In Commercial Distribution

  • M697C07300870 ()
  • M697C07300871 ()


  • Surgical screwdriver, reusable
SPECIALTY XPRESS DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0072
In Commercial Distribution

  • M697C07300720 ()
  • M697C07300721 ()


  • Surgical screwdriver, reusable
SPECIALTY XPRESS SHORTENED PEDICLE SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0071
In Commercial Distribution

  • M697C07300710 ()
  • M697C07300711 ()


  • Surgical screwdriver, reusable
SPECIALTY XPRESS SHORTENED PEDICLE SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0069
In Commercial Distribution

  • M697C07300690 ()
  • M697C07300691 ()


  • Surgical screwdriver, reusable
SPECIALTY XPRESS SHORTENED FINAL CAP DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0067
In Commercial Distribution

  • M697C07300670 ()
  • M697C07300671 ()


  • Surgical screwdriver, reusable
SPECIALTY SHORTENED INLINE CAP INTRODUCER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0066
In Commercial Distribution

  • M697C07300660 ()
  • M697C07300661 ()


  • Surgical screwdriver, reusable
SPECIALTY XPRESS NAVIGATION DRIVER
Xtant Medical Holdings, Inc.
C073-0059
In Commercial Distribution

  • M697C07300590 ()
  • M697C07300591 ()


  • Surgical screwdriver, reusable
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