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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AWL EX0711448 PEDICLE AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX0711448
In Commercial Distribution

  • 00643169063983 ()


  • Bone awl, reusable
COUNTER TORQUE EX0711455 4.75
MEDTRONIC SOFAMOR DANEK, INC.
EX0711455
In Commercial Distribution

  • 00643169062122 ()


  • Orthopaedic counter-torque/rod-pushing instrument
GUIDE EX0811459 FIXED DRILL
MEDTRONIC SOFAMOR DANEK, INC.
EX0811459
In Commercial Distribution

  • 00643169061996 ()


  • Surgical drill guide, reusable
AWL EX0811458 FIXED RETRACTABLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0811458
In Commercial Distribution

  • 00643169061989 ()


  • Bone awl, reusable
RETRACTOR EX0711497 NERVE
MEDTRONIC SOFAMOR DANEK, INC.
EX0711497
In Commercial Distribution

  • 00643169061811 ()


  • Surgical retractor/retraction system blade, reusable
DRIVER EX0811450 5.5 MAS W/CROSSBAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0811450
In Commercial Distribution

  • 00643169061798 ()


  • Orthopaedic implant driver
DRIVER EX0811294 ASSY 5.5 MAS WELDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0811294
In Commercial Distribution

  • 00643169061781 ()


  • Orthopaedic implant driver
OSTEOTOME EX0811303 8MM CUTTING
MEDTRONIC SOFAMOR DANEK, INC.
EX0811303
In Commercial Distribution

  • 00643169061750 ()


  • Orthopaedic osteotome
PIN RECEPTACLE EX0711503 DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX0711503
In Commercial Distribution

  • 00643169061682 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX0711502 CERVICAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0711502
In Commercial Distribution

  • 00643169061675 ()


  • Orthopaedic surgical distractor, internal
TAP X0711580 3.5MM TAPERED SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0711580
In Commercial Distribution

  • 00643169060760 ()


  • Bone tap, reusable
RASP X0811307 4MM ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
X0811307
In Commercial Distribution

  • 00643169060753 ()


  • Bone file/rasp, manual, reusable
RASP X0811306 3MM ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
X0811306
In Commercial Distribution

  • 00643169060746 ()


  • Bone file/rasp, manual, reusable
RASP X0811305 2MM ANGLEG
MEDTRONIC SOFAMOR DANEK, INC.
X0811305
In Commercial Distribution

  • 00643169060739 ()


  • Bone file/rasp, manual, reusable
ELEVATOR X0811304 FACET FREER
MEDTRONIC SOFAMOR DANEK, INC.
X0811304
In Commercial Distribution

  • 00643169060722 ()


  • Bone lever/elevator, reusable
DRIVER X0811006 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X0811006
In Commercial Distribution

  • 00643169060715 ()


  • Surgical screwdriver, reusable
DISTRACTOR EX0711577 BAYONETTED
MEDTRONIC SOFAMOR DANEK, INC.
EX0711577
In Commercial Distribution

  • 00643169060579 ()


  • Orthopaedic surgical distractor, internal
TREPHINE X0811126 3.6MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811126
In Commercial Distribution

  • 00643169060272 ()


  • Bone trephine, reusable
DISTRACTOR X0811234 SHAFT 18MM STD-TYPE
MEDTRONIC SOFAMOR DANEK, INC.
X0811234
In Commercial Distribution

  • 00643169060005 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0811233 SHAFT 16MM STD-TYPE
MEDTRONIC SOFAMOR DANEK, INC.
X0811233
In Commercial Distribution

  • 00643169059993 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0811232 TIP 10X20 MODIFIED
MEDTRONIC SOFAMOR DANEK, INC.
X0811232
In Commercial Distribution

  • 00643169059986 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0811231 TIP 10X18 MODIFIED
MEDTRONIC SOFAMOR DANEK, INC.
X0811231
In Commercial Distribution

  • 00643169059979 ()


  • Orthopaedic surgical distractor, internal
CURETTE X0811291 BAYONET
MEDTRONIC SOFAMOR DANEK, INC.
X0811291
In Commercial Distribution

  • 00643169059900 ()


  • Bone curette, reusable
12DEG RASP X0411358 18MM
MEDTRONIC SOFAMOR DANEK, INC.
X0411358
In Commercial Distribution

  • 00643169059719 ()


  • Bone file/rasp, manual, reusable
12DEG RASP X0411356 16MM
MEDTRONIC SOFAMOR DANEK, INC.
X0411356
In Commercial Distribution

  • 00643169059702 ()


  • Bone file/rasp, manual, reusable
12DEG RASP X0411354 14MM
MEDTRONIC SOFAMOR DANEK, INC.
X0411354
In Commercial Distribution

  • 00643169059696 ()


  • Bone file/rasp, manual, reusable
12DEG RASP X0411352 12MM
MEDTRONIC SOFAMOR DANEK, INC.
X0411352
In Commercial Distribution

  • 00643169059689 ()


  • Bone file/rasp, manual, reusable
12DEG RASP X0411350 10MM
MEDTRONIC SOFAMOR DANEK, INC.
X0411350
In Commercial Distribution

  • 00643169059672 ()


  • Bone file/rasp, manual, reusable
12DEG RASP X0411348 8MM
MEDTRONIC SOFAMOR DANEK, INC.
X0411348
In Commercial Distribution

  • 00643169059665 ()


  • Bone file/rasp, manual, reusable
HANDLE EX0711461 SMLL RATCHET 6.32 SQ QC
MEDTRONIC SOFAMOR DANEK, INC.
EX0711461
In Commercial Distribution

  • 00643169058910 ()


  • Surgical instrument handle, non-torque-limiting
PROBE X1010187 FEELER 2MM
MEDTRONIC SOFAMOR DANEK, INC.
X1010187
In Commercial Distribution

  • 00643169058873 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
CAM SPREADER TRIAL 4000015 6 DEG 15MM
MEDTRONIC SOFAMOR DANEK, INC.
4000015
In Commercial Distribution

  • 00643169056138 ()

  • MM=15
  • Angle: 6.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 4000014 6 DEG 14MM
MEDTRONIC SOFAMOR DANEK, INC.
4000014
In Commercial Distribution

  • 00643169056121 ()

  • MM=14
  • Angle: 6.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 4000013 6 DEG 13MM
MEDTRONIC SOFAMOR DANEK, INC.
4000013
In Commercial Distribution

  • 00643169056114 ()

  • Angle: 6.0 degree
  • MM=13


  • Spinal implant trial
CAM SPREADER TRIAL 4000012 6 DEG 12MM
MEDTRONIC SOFAMOR DANEK, INC.
4000012
In Commercial Distribution

  • 00643169056107 ()

  • MM=12
  • Angle: 6.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 4000011 6 DEG 11MM
MEDTRONIC SOFAMOR DANEK, INC.
4000011
In Commercial Distribution

  • 00643169056091 ()

  • MM=11
  • Angle: 6.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 4000010 6 DEG 10MM
MEDTRONIC SOFAMOR DANEK, INC.
4000010
In Commercial Distribution

  • 00643169056084 ()

  • Angle: 6.0 degree
  • MM10


  • Spinal implant trial
CAM SPREADER TRIAL 3990017 0 DEG 17MM
MEDTRONIC SOFAMOR DANEK, INC.
3990017
In Commercial Distribution

  • 00643169056060 ()

  • MM=17
  • Angle: 0.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 3990016 0 DEG 16MM
MEDTRONIC SOFAMOR DANEK, INC.
3990016
In Commercial Distribution

  • 00643169056053 ()

  • MM=16
  • Angle: 0.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 3990015 0 DEG 15MM
MEDTRONIC SOFAMOR DANEK, INC.
3990015
In Commercial Distribution

  • 00643169056046 ()

  • MM=15
  • Angle: 0.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 3990014 0 DEG 14MM
MEDTRONIC SOFAMOR DANEK, INC.
3990014
In Commercial Distribution

  • 00643169056039 ()

  • MM=14
  • Angle: 0.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 3990013 0 DEG 13MM
MEDTRONIC SOFAMOR DANEK, INC.
3990013
In Commercial Distribution

  • 00643169056022 ()

  • Angle: 0.0 degree
  • MM=13


  • Spinal implant trial
CAM SPREADER TRIAL 3990012 0 DEG 12MM
MEDTRONIC SOFAMOR DANEK, INC.
3990012
In Commercial Distribution

  • 00643169056015 ()

  • MM=12
  • Angle: 0.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 3990011 0 DEG 11MM
MEDTRONIC SOFAMOR DANEK, INC.
3990011
In Commercial Distribution

  • 00643169056008 ()

  • MM=11
  • Angle: 0.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 3990010 0 DEG 10MM
MEDTRONIC SOFAMOR DANEK, INC.
3990010
In Commercial Distribution

  • 00643169055995 ()

  • MM=10
  • Angle: 0.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 3990009 0 DEG 9MM
MEDTRONIC SOFAMOR DANEK, INC.
3990009
In Commercial Distribution

  • 00643169055988 ()

  • Angle: 0.0 degree
  • MM=9


  • Spinal implant trial
CAM SPREADER TRIAL 3990008 0 DEG 8MM
MEDTRONIC SOFAMOR DANEK, INC.
3990008
In Commercial Distribution

  • 00643169055971 ()

  • Angle: 0.0 degree
  • MM=8


  • Spinal implant trial
CAM SPREADER TRIAL 4000016 6 DEG 16MM
MEDTRONIC SOFAMOR DANEK, INC.
4000016
In Commercial Distribution

  • 00643169055964 ()

  • Angle: 6.0 degree
  • MM=16


  • Spinal implant trial
CAM SPREADER TRIAL 4020017 18 DEG 17MM
MEDTRONIC SOFAMOR DANEK, INC.
4020017
In Commercial Distribution

  • 00643169055940 ()

  • MM=17
  • Angle: 18.0 degree


  • Spinal implant trial
CAM SPREADER TRIAL 4020016 18 DEG 16MM
MEDTRONIC SOFAMOR DANEK, INC.
4020016
In Commercial Distribution

  • 00643169055933 ()

  • MM=16
  • Angle: 18.0 degree


  • Spinal implant trial
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