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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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12.5mm IMPLANT DRIVER ASSY, CANNULATED
Xtant Medical Holdings, Inc.
X079-0060
In Commercial Distribution

  • M697X07900600 ()
  • M697X07900601 ()

  • Outer Diameter: 12.5 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
7mm ADJUSTMENT IMPLANT DRIVER, CANNULATED
Xtant Medical Holdings, Inc.
X079-0033
In Commercial Distribution

  • M697X07900330 ()
  • M697X07900331 ()

  • Outer Diameter: 7 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
7mm IMPLANT DRIVER ASSY, CANNULATED
Xtant Medical Holdings, Inc.
X079-0030
In Commercial Distribution

  • M697X07900300 ()
  • M697X07900301 ()

  • Outer Diameter: 7 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Cross Connector, Locking Driver
Xtant Medical Holdings, Inc.
X070-0040
In Commercial Distribution

  • M697X07000400 ()
  • M697X07000401 ()


  • Surgical screwdriver, reusable
ASSY, OCCIPITAL UNIVERSAL JOINT DRIVER TAP
Xtant Medical Holdings, Inc.
X067-1050
Not in Commercial Distribution

  • M697X06710500 ()
  • M697X06710501 ()


  • Bone tap, reusable
Assy, Occipital Universal Joint Driver, Self-Retaining
Xtant Medical Holdings, Inc.
X067-1000
Not in Commercial Distribution

  • M697X06710000 ()
  • M697X06710001 ()


  • Surgical screwdriver, reusable
TORQUE DRIVER T-HANDLE, 1/4" SQUARE CONNECT
Xtant Medical Holdings, Inc.
X067-0805
Not in Commercial Distribution

  • M697X06708050 ()
  • M697X06708051 ()


  • Surgical instrument handle, torque-limiting
ASSEMBLY, CAP DRIVER, SELF-RETAINING
Xtant Medical Holdings, Inc.
X067-0520
Not in Commercial Distribution

  • M697X06705200 ()
  • M697X06705201 ()


  • Surgical screwdriver, reusable
A/O Torque Driver Handle
Xtant Medical Holdings, Inc.
X060-0323
In Commercial Distribution

  • M697X06003230 ()
  • M697X06003231 ()


  • Lumbar interspinous decompression instrument set, reusable
Ø3.0mm (6") Drill
Tyber Medical LLC
HTR-04-139866
In Commercial Distribution

  • M695HTR041398660 ()
HTR-04-139866

  • Cannulated surgical drill bit, single-use
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