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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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Silex Sacroiliac Joint Fusion System - M697C07900381

SPECIALTY #2 STS MORE AGGRESSIVE TIP
Xtant Medical Holdings, Inc.
C079-0038
In Commercial Distribution

  • M697C07900380 ()
  • M697C07900381 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Zyfix Spinal Facet Screw System - M697C07600061

Specialty Luer Lock adapter for Osteosponge putty syringe
Xtant Medical Holdings, Inc.
C076-0006
In Commercial Distribution

  • M697C07600060 ()
  • M697C07600061 ()


  • General-purpose syringe, single-use

Zyfix Spinal Facet Screw System - M697C07600041

Specialty Luer Lock adapter for Osteosponge putty syringe
Xtant Medical Holdings, Inc.
C076-0004
In Commercial Distribution

  • M697C07600040 ()
  • M697C07600041 ()


  • General-purpose syringe, single-use

Xpress Minimally Invasive Pedicle Screw System - M697C07300981

8.25mm Dual Lead Tap, Cannulated
Xtant Medical Holdings, Inc.
C073-0098
In Commercial Distribution

  • M697C07300980 ()
  • M697C07300981 ()

  • Outer Diameter: 8.25 Millimeter


  • Bone tap, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300961

6.5mm Dual Lead Tap, Cannulated
Xtant Medical Holdings, Inc.
C073-0096
In Commercial Distribution

  • M697C07300960 ()
  • M697C07300961 ()

  • Outer Diameter: 6.5 Millimeter


  • Bone tap, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300951

5.5mm Dual Lead Tap, Cannulated
Xtant Medical Holdings, Inc.
C073-0095
In Commercial Distribution

  • M697C07300950 ()
  • M697C07300951 ()

  • Outer Diameter: 5.5 Millimeter


  • Bone tap, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300931

5.5mm Dual Lead Tap, Non-Cannulated
Xtant Medical Holdings, Inc.
C010-0084
In Commercial Distribution

  • M697C07300930 ()
  • M697C07300931 ()


  • Bone tap, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300911

Specialty Rod Length Indicator - Solid Post Version
Xtant Medical Holdings, Inc.
C073-0091
In Commercial Distribution

  • M697C07300910 ()
  • M697C07300911 ()


  • Surgical implant template, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300891

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

  • M697C07300890 ()
  • M697C07300891 ()


  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300871

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

  • M697C07300870 ()
  • M697C07300871 ()


  • Surgical screwdriver, reusable
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