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

  • M697X06710500 ()
  • M697X06710501 ()


  • Bone tap, reusable
OCCIPITAL FIXED ANGLE CAP DRIVER
Xtant Medical Holdings, Inc.
X067-1028
Not in Commercial Distribution

  • M697X06710280 ()
  • M697X06710281 ()


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

  • M697X06710000 ()
  • M697X06710001 ()


  • Surgical screwdriver, reusable
ASSY, HEX DRIVER GUIDE
Xtant Medical Holdings, Inc.
X067-0850
Not in Commercial Distribution

  • M697X06708500 ()
  • M697X06708501 ()


  • Orthopaedic implantation sleeve, reusable
Multi Screw Driver
BK MEDITECH CO.,LTD.
61630-70
In Commercial Distribution

  • 08809763492259 ()


  • Surgical screwdriver, reusable
Long-Arm Screw Driver
BK MEDITECH CO.,LTD.
61620-70
In Commercial Distribution

  • 08809763492242 ()


  • Surgical screwdriver, reusable
ASSEMBLY, CAP DRIVER, SELF-RETAINING
Xtant Medical Holdings, Inc.
X067-0520
Not in Commercial Distribution

  • M697X06705200 ()
  • M697X06705201 ()


  • Surgical screwdriver, reusable
CROSS CONNECTOR LOCKING DRIVER
Xtant Medical Holdings, Inc.
X067-0425
Not in Commercial Distribution

  • M697X06704250 ()
  • M697X06704251 ()


  • Surgical screwdriver, reusable
Reduction Pedicle Screwdriver Assembly
Xtant Medical Holdings, Inc.
X064-0140
In Commercial Distribution

  • M697X06401400 ()
  • M697X06401401 ()


  • Surgical screwdriver, reusable
MALLET, ASSY
Xtant Medical Holdings, Inc.
X063-0055
In Commercial Distribution

  • M697X06300550 ()
  • M697X06300551 ()


  • Surgical mallet
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