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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ADAPTOR X1106093 TRI FLAT QUICK CONNECT
MEDTRONIC SOFAMOR DANEK, INC.
X1106093
In Commercial Distribution

  • 00613994289285 ()


  • Surgical screwdriver, reusable
TRIAL 9874139 DOUBLE-ENDED 39MM 41MM
MEDTRONIC SOFAMOR DANEK, INC.
9874139
In Commercial Distribution

  • 00613994285133 ()


  • Spinal implant trial
TRIAL 9874143 DOUBLE-ENDED 43MM 45MM
MEDTRONIC SOFAMOR DANEK, INC.
9874143
In Commercial Distribution

  • 00613994285119 ()


  • Spinal implant trial
HOLDER 9874145 STAND ALONE
MEDTRONIC SOFAMOR DANEK, INC.
9874145
In Commercial Distribution

  • 00613994285102 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
PLATE HOLDER 9874640 4 HOLE
MEDTRONIC SOFAMOR DANEK, INC.
9874640
In Commercial Distribution

  • 00613994285096 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
HOLDER 9870001 4HOLE PLATE FREE HAND
MEDTRONIC SOFAMOR DANEK, INC.
9870001
In Commercial Distribution

  • 00613994284983 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL 9874135 DOUBLE-ENDED 35MM 37MM
MEDTRONIC SOFAMOR DANEK, INC.
9874135
In Commercial Distribution

  • 00613994284914 ()


  • Spinal implant trial
GUIDE 9874133 DBL BARREL 0 DEG
MEDTRONIC SOFAMOR DANEK, INC.
9874133
In Commercial Distribution

  • 00613994284907 ()


  • Surgical implant/trial-implant/sizer holder, reusable
DRIVER 8350305 SCREW ADJUSTMENT
MEDTRONIC SOFAMOR DANEK, INC.
8350305
In Commercial Distribution

  • 00613994282552 ()


  • Orthopaedic implant driver
DRILL GUIDE X0705191 WITH FOOT
MEDTRONIC SOFAMOR DANEK, INC.
X0705191
In Commercial Distribution

  • 00613994272430 ()


  • Surgical drill guide, reusable
TAP X1106170 PEAR HANDLE 7.0MM
MEDTRONIC SOFAMOR DANEK, INC.
X1106170
In Commercial Distribution

  • 00613994270801 ()


  • Bone tap, reusable
DISTRACTOR X0706009 POSTERIOR
MEDTRONIC SOFAMOR DANEK, INC.
X0706009
In Commercial Distribution

  • 00613994266033 ()


  • Orthopaedic surgical distractor, internal
TRIAL 9359525 25MM
MEDTRONIC SOFAMOR DANEK, INC.
9359525
In Commercial Distribution

  • 00613994265579 ()


  • Spinal implant trial
TRIAL 9359522 22MM
MEDTRONIC SOFAMOR DANEK, INC.
9359522
In Commercial Distribution

  • 00613994265562 ()


  • Spinal implant trial
TRIAL 9359519 19MM
MEDTRONIC SOFAMOR DANEK, INC.
9359519
In Commercial Distribution

  • 00613994265555 ()


  • Spinal implant trial
TRIAL 9359516 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9359516
In Commercial Distribution

  • 00613994265548 ()


  • Spinal implant trial
TRIAL 9359513 13MM
MEDTRONIC SOFAMOR DANEK, INC.
9359513
In Commercial Distribution

  • 00613994265531 ()


  • Spinal implant trial
HOLDER X0806165 ROD 5.5 WITHOUT LOCK
MEDTRONIC SOFAMOR DANEK, INC.
X0806165
In Commercial Distribution

  • 00613994264596 ()


  • Surgical implant/trial-implant/sizer holder, reusable
HANDLE X1006014 BAYONET FOR SCALPEL
MEDTRONIC SOFAMOR DANEK, INC.
X1006014
In Commercial Distribution

  • 00613994264169 ()


  • Surgical instrument handle, non-torque-limiting
DRIVER X0907071 3.5 CAPTIVE TWIST HEX SS
MEDTRONIC SOFAMOR DANEK, INC.
X0907071
In Commercial Distribution

  • 00613994410672 ()


  • Surgical drill guide, reusable
DISTRACTOR X0805171 INLINE
MEDTRONIC SOFAMOR DANEK, INC.
X0805171
In Commercial Distribution

  • 00613994378903 ()


  • Orthopaedic surgical distractor, internal
HANDLE X0906194 NIM PROBE BALL ATT
MEDTRONIC SOFAMOR DANEK, INC.
X0906194
In Commercial Distribution

  • 00613994375117 ()


  • Nerve-locating system
DISTRACTOR X0706200 12MM SQUARE END
MEDTRONIC SOFAMOR DANEK, INC.
X0706200
In Commercial Distribution

  • 00613994404527 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0706194 10MM SQUARE END
MEDTRONIC SOFAMOR DANEK, INC.
X0706194
In Commercial Distribution

  • 00613994404510 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0706188 8MM SQUARE END
MEDTRONIC SOFAMOR DANEK, INC.
X0706188
In Commercial Distribution

  • 00613994404503 ()


  • Orthopaedic surgical distractor, internal
INSTRUMENT 7081914 RATCHET RELEASE
MEDTRONIC SOFAMOR DANEK, INC.
7081914
In Commercial Distribution

  • 00613994399830 ()


  • Instrument tray, reusable
DRIVER 9010000144 BONE SCREW ADJUSTMENT
MEDTRONIC SOFAMOR DANEK, INC.
9010000144
In Commercial Distribution

  • 00613994694041 ()


  • Surgical screwdriver, reusable
RASP X0707110
MEDTRONIC SOFAMOR DANEK, INC.
X0707110
In Commercial Distribution

  • 00613994687470 ()


  • Bone file/rasp, manual, reusable
ADJUSTER 9391300 IN SITU
MEDTRONIC SOFAMOR DANEK, INC.
9391300
In Commercial Distribution

  • 00613994683717 ()


  • Orthopaedic fixation implant alignment tool
REMOVER 9401200 END CAP REMOVER
MEDTRONIC SOFAMOR DANEK, INC.
9401200
In Commercial Distribution

  • 00613994683601 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
INSERTER 9411600 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9411600
In Commercial Distribution

  • 00613994683588 ()

  • Outer Diameter: 16.0 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSERTER 9412200 22MM
MEDTRONIC SOFAMOR DANEK, INC.
9412200
In Commercial Distribution

  • 00613994683564 ()

  • Outer Diameter: 22.0 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSERTER 9412500 25MM
MEDTRONIC SOFAMOR DANEK, INC.
9412500
In Commercial Distribution

  • 00613994683557 ()

  • Outer Diameter: 25.0 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
AWL X1108166 FIXED ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
X1108166
In Commercial Distribution

  • 00613994683182 ()


  • Bone awl, reusable
PROBE X1106040 LUMBAR
MEDTRONIC SOFAMOR DANEK, INC.
X1106040
In Commercial Distribution

  • 00613994667564 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
BLADE X030729213 NARROW 13
MEDTRONIC SOFAMOR DANEK, INC.
X030729213
In Commercial Distribution

  • 00613994667533 ()


  • Orthopaedic knife
BLADE X0409170 DISCECTOMY EXTRA WIDE 70
MEDTRONIC SOFAMOR DANEK, INC.
X0409170
In Commercial Distribution

  • 00613994639684 ()


  • Orthopaedic knife
BLADE X0409150 DISCECTOMY EXTRA WIDE 50
MEDTRONIC SOFAMOR DANEK, INC.
X0409150
In Commercial Distribution

  • 00613994639660 ()


  • Orthopaedic knife
BLADE X0409140 DISCECTOMY EXTRA WIDE 40
MEDTRONIC SOFAMOR DANEK, INC.
X0409140
In Commercial Distribution

  • 00613994639653 ()


  • Orthopaedic knife
BLADE X0409130 DISCECTOMY EXTRA WIDE 30
MEDTRONIC SOFAMOR DANEK, INC.
X0409130
In Commercial Distribution

  • 00613994639646 ()


  • Orthopaedic knife
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