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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TRIAL X0420013 16DEG 16MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420013
In Commercial Distribution

  • 00763000940454 ()


  • Spinal implant trial
TRIAL X0420011 16DEG 12MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420011
In Commercial Distribution

  • 00763000940430 ()


  • Spinal implant trial
TRIAL X0420010 16DEG 10MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420010
In Commercial Distribution

  • 00763000940423 ()


  • Spinal implant trial
TRIAL X0420009 16DEG 20MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420009
In Commercial Distribution

  • 00763000940416 ()


  • Spinal implant trial
TRIAL X0420008 16DEG 18MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420008
In Commercial Distribution

  • 00763000940409 ()


  • Spinal implant trial
TRIAL X0420007 16DEG 16MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420007
In Commercial Distribution

  • 00763000940393 ()


  • Spinal implant trial
TRIAL X0420006 16DEG 14MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420006
In Commercial Distribution

  • 00763000940386 ()


  • Spinal implant trial
TRIAL X0420005 16DEG 12MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420005
In Commercial Distribution

  • 00763000940379 ()


  • Spinal implant trial
TRIAL X0420004 16DEG 10MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420004
In Commercial Distribution

  • 00763000940362 ()


  • Spinal implant trial
HANDLE X3606177 REDUCER T
MEDTRONIC SOFAMOR DANEK, INC.
X3606177
In Commercial Distribution

  • 00763000931711 ()


  • Orthopaedic rod reducer
REDUCER X3606176 SEQUENTIAL ROD
MEDTRONIC SOFAMOR DANEK, INC.
X3606176
In Commercial Distribution

  • 00763000931704 ()


  • Orthopaedic rod reducer
REFERENCE X0723001 ROD 5.5/6.0 SHORT
MEDTRONIC SOFAMOR DANEK, INC.
X0723001
In Commercial Distribution

  • 00763000920036 ()


  • Surgical implant template, reusable
RASP EX1023212 LS SMALL 12DEG 32X25X12MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1023212
In Commercial Distribution

  • 00763000919665 ()


  • Bone file/rasp, manual, reusable
DRILL BIT EX0923004 UCSS FLEX SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0923004
In Commercial Distribution

  • 00763000918057 ()


  • Drilling power tool attachment, basic
GUIDE EX0923002 UCSS SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0923002
In Commercial Distribution

  • 00763000918033 ()


  • General internal orthopaedic fixation system implantation kit
BENDER EX1023002 5.5/6.0MM SAGITTAL ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1023002
In Commercial Distribution

  • 00763000917999 ()


  • Manual orthopaedic bender, reusable
DEROTATOR EX0923006 APICAL 5.5/6.0
MEDTRONIC SOFAMOR DANEK, INC.
EX0923006
In Commercial Distribution

  • 00763000917982 ()


  • Orthopaedic counter-torque/rod-pushing instrument
RETRACTOR EX0923001 8 HAND-HELD TISSUE
MEDTRONIC SOFAMOR DANEK, INC.
EX0923001
In Commercial Distribution

  • 00763000914028 ()


  • Surgical retractor/retraction system blade, reusable
DISTRACTOR EX0823016 16MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0823016
In Commercial Distribution

  • 00763000914011 ()


  • Surgical screwdriver, reusable
DRIVER EX1023007 T27 NON-BREAK OFF SETSW
MEDTRONIC SOFAMOR DANEK, INC.
EX1023007
In Commercial Distribution

  • 00763000913991 ()


  • Surgical screwdriver, reusable
PROBE EX0823010 STRAIT SHARP TIP PEDICLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0823010
In Commercial Distribution

  • 00763000913984 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
RETRACTOR EX0823270 70MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823270
In Commercial Distribution

  • 00763000913960 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0823260 60MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823260
In Commercial Distribution

  • 00763000913953 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0823250 50MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823250
In Commercial Distribution

  • 00763000913946 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0823160 60MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823160
In Commercial Distribution

  • 00763000913922 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0823150 50MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823150
In Commercial Distribution

  • 00763000913915 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0823130 30MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823130
In Commercial Distribution

  • 00763000913892 ()


  • Surgical retractor/retraction system blade, reusable
ROD FRAME X0423002 5.5MM SHORT
MEDTRONIC SOFAMOR DANEK, INC.
X0423002
In Commercial Distribution

  • 00763000920029 ()


  • Surgical implant template, reusable
RASP EX1023112 TL 12DEG 20W 12X60MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1023112
In Commercial Distribution

  • 00763000919689 ()


  • Bone file/rasp, manual, reusable
RASP EX1023110 TL 12DEG 20W 10X60MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1023110
In Commercial Distribution

  • 00763000919672 ()


  • Bone file/rasp, manual, reusable
RASP EX1023210 LS SMALL 12DEG 32X25X10MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1023210
In Commercial Distribution

  • 00763000919658 ()


  • Bone file/rasp, manual, reusable
SCREWDRIVER EX0923003 UCSS FLEX SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0923003
In Commercial Distribution

  • 00763000918040 ()


  • Surgical screwdriver, reusable
LAMINA EX0923005 SPREADER
MEDTRONIC SOFAMOR DANEK, INC.
EX0923005
In Commercial Distribution

  • 00763000918026 ()


  • Bone distraction forceps
DISTRACTOR EX0823015 15MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0823015
In Commercial Distribution

  • 00763000914004 ()


  • Orthopaedic surgical distractor, internal
RETRACTOR EX0823280 80MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823280
In Commercial Distribution

  • 00763000913977 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0823170 70MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823170
In Commercial Distribution

  • 00763000913939 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0823140 40MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823140
In Commercial Distribution

  • 00763000913908 ()


  • Surgical retractor/retraction system blade, reusable
DRILL GUIDE X0916068 INTRADISCAL 6MM
MEDTRONIC SOFAMOR DANEK, INC.
X0916068
In Commercial Distribution

  • 00763000998165 ()


  • Surgical drill guide, reusable
DRIVER X5599125 MDLX ASM
MEDTRONIC SOFAMOR DANEK, INC.
X5599125
In Commercial Distribution

  • 00763000989491 ()


  • Surgical screwdriver, reusable
DRIVER X5597185 MDLX LARGER DIAMETE MT25
MEDTRONIC SOFAMOR DANEK, INC.
X5597185
In Commercial Distribution

  • 00763000988524 ()


  • Orthopaedic implant driver
DRIVER X5598043 MDLX PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
X5598043
In Commercial Distribution

  • 00763000988395 ()


  • Orthopaedic implant driver
SHIM X07318163 SS PRELOADED 6MM X 15MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318163
In Commercial Distribution

  • 00763000986513 ()


  • Surgical retractor/retraction system blade, reusable
SHIM X07318143 SS PRELOADED 4MM X 15MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318143
In Commercial Distribution

  • 00763000986506 ()


  • Surgical retractor/retraction system blade, reusable
BLADE X07318342 SS SHIM SLIM LT 4MMX35MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318342
In Commercial Distribution

  • 00763000986476 ()


  • Surgical retractor/retraction system blade, reusable
BLADE X07318282 SS SHIM SLIM LT 8MMX25MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318282
In Commercial Distribution

  • 00763000986469 ()


  • Surgical retractor/retraction system blade, reusable
BLADE X07318262 SS SHIM SLIM LT 6MMX25MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318262
In Commercial Distribution

  • 00763000986452 ()


  • Surgical retractor/retraction system blade, reusable
BLADE X07318182 SS SHIM SLIM LT 8MMX15MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318182
In Commercial Distribution

  • 00763000986438 ()


  • Surgical retractor/retraction system blade, reusable
BLADE X07318142 SS SHIM SLIM LT 4MMX15MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318142
In Commercial Distribution

  • 00763000986414 ()


  • Surgical retractor/retraction system blade, reusable
INDICATOR X07318171 SS 170MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318171
In Commercial Distribution

  • 00763000986391 ()


  • Surgical retractor/retraction system blade, reusable
INDICATOR X07318151 SS 150MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318151
In Commercial Distribution

  • 00763000986384 ()


  • Surgical retractor/retraction system blade, reusable
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