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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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TSRH® Spinal System - 00721902981166

TSR VAS-TI-10.0X40
MEDTRONIC SOFAMOR DANEK, INC.
X1103140
In Commercial Distribution

  • 00721902981166 ()

  • Outer Diameter: 10.0 Millimeter
  • Length: 40.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

TSRH® Spinal System - 00721902981159

TSR VAS-TI-10.0X35
MEDTRONIC SOFAMOR DANEK, INC.
X1103135
In Commercial Distribution

  • 00721902981159 ()

  • Outer Diameter: 10.0 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

TSRH® Spinal System - 00721902981128

TSR VAS-TI-11.0X45
MEDTRONIC SOFAMOR DANEK, INC.
X11031145
In Commercial Distribution

  • 00721902981128 ()

  • Outer Diameter: 11.0 Millimeter
  • Length: 45.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD HORIZON® Spinal System - 00721902979507

CDH LEGACY 4.5 CANN MAS 4.5X45
MEDTRONIC SOFAMOR DANEK, INC.
7654545
In Commercial Distribution

  • 00721902979507 ()


  • Spinal bone screw, non-bioabsorbable

N/A - 00721902977985

BUR 1883212HSE SEPTOPLASTY HI SPD 3.2MM
MEDTRONIC XOMED, INC.
1883212HSE
Not in Commercial Distribution

  • 00721902977985 ()

  • Length: 3.2 Millimeter
  • Outer Diameter: 12.0 Millimeter


  • Metal/carbide ENT bur, single-use

TSRH® Spinal System - 00721902977305

7.5 X 45MM SACRAL SCREW
MEDTRONIC SOFAMOR DANEK, INC.
8373745
Not in Commercial Distribution

  • 00721902977305 ()


  • Spinal bone screw, non-bioabsorbable

N/A - 00721902976827

CASE 3280061 ALIF KIT BASE
MEDTRONIC SOFAMOR DANEK, INC.
3280061
In Commercial Distribution

  • 00721902976827 ()


  • Instrument tray, reusable

n/a - 00721902976810

CASE 3280052 GENERAL KIT UPPER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
3280052
In Commercial Distribution

  • 00721902976810 ()


  • Instrument tray, reusable

n/a - 00721902976803

CASE 3280051 GENERAL KIT MIDDLE TRAY
MEDTRONIC SOFAMOR DANEK, INC.
3280051
In Commercial Distribution

  • 00721902976803 ()


  • Instrument tray, reusable

n/a - 00721902976797

CASE 3280050 GENERAL KIT LOWER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
3280050
In Commercial Distribution

  • 00721902976797 ()


  • Instrument tray, reusable

n/a - 00721902976780

CASE 3280048 GENERAL KIT BASE
MEDTRONIC SOFAMOR DANEK, INC.
3280048
In Commercial Distribution

  • 00721902976780 ()


  • Instrument tray, reusable

Medtronic Reusable Instruments - 00721902975912

18MM MODIFIED TAP
MEDTRONIC SOFAMOR DANEK, INC.
YIB0700-017
Not in Commercial Distribution

  • 00721902975912 ()


  • Bone tap, reusable

Medtronic Reusable Instruments - 00721902975899

18MM MODIFIED REAMER
MEDTRONIC SOFAMOR DANEK, INC.
YIB0700-016
Not in Commercial Distribution

  • 00721902975899 ()


  • Orthopaedic broach

GDLH® Posterior Spinal System - 00721902975158

ROD 5.5X11CM-TI-HEX
MEDTRONIC SOFAMOR DANEK, INC.
X0196-111
In Commercial Distribution

  • 00721902975158 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 11.0 Centimeter


  • Spinal bone screw, non-bioabsorbable

Medtronic Reusable Instruments - 00721902975073

INSTRUMENT 2900260 15MMX18 SPREADER
MEDTRONIC SOFAMOR DANEK, INC.
2900260
In Commercial Distribution

  • 00721902975073 ()


  • Bone distraction forceps

Medtronic Reusable Instruments - 00721902975004

INSTRUMENT 2900259 13MMX18 SPREADER
MEDTRONIC SOFAMOR DANEK, INC.
2900259
In Commercial Distribution

  • 00721902975004 ()


  • Bone distraction forceps

Medtronic Reusable Instruments - 00721902974830

INSTRUMENT 9561526 SELFRETAIN RTRCT POST
MEDTRONIC SOFAMOR DANEK, INC.
9561526
In Commercial Distribution

  • 00721902974830 ()


  • Orthopaedic fixation implant alignment tool

N/A - 00721902974274

CASE 6971410 PRESTIGE LP OUTER LID
MEDTRONIC SOFAMOR DANEK, INC.
6971410
In Commercial Distribution

  • 00721902974274 ()


  • Instrument tray, reusable

N/A - 00721902974267

CASE 6971407 PRSTG LP INNER TRAY MIDDLE
MEDTRONIC SOFAMOR DANEK, INC.
6971407
In Commercial Distribution

  • 00721902974267 ()


  • Instrument tray, reusable

N/A - 00721902974250

CASE 6971406 PRSTG LP INNER TRAY LOWER
MEDTRONIC SOFAMOR DANEK, INC.
6971406
In Commercial Distribution

  • 00721902974250 ()


  • Instrument tray, reusable
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