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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FORK EX0613043 ALIGNMENT
MEDTRONIC SOFAMOR DANEK, INC.
EX0613043
In Commercial Distribution

  • 00643169368934 ()


  • General internal orthopaedic fixation system implantation kit
TUBULAR RETRACTOR X0613049 18 MM X 90 MM
MEDTRONIC SOFAMOR DANEK, INC.
X0613049
In Commercial Distribution

  • 00643169368927 ()


  • Surgical retractor/retraction system blade, reusable
TUBULAR RETRACTOR X0613048 18 MM X 80 MM
MEDTRONIC SOFAMOR DANEK, INC.
X0613048
In Commercial Distribution

  • 00643169368910 ()


  • Surgical retractor/retraction system blade, reusable
RASP X0213187 9X14X11 WITHOUT STOP
MEDTRONIC SOFAMOR DANEK, INC.
X0213187
In Commercial Distribution

  • 00643169368385 ()


  • Bone file/rasp, manual, reusable
RASP X0213186 8X14X11 WITHOUT STOP
MEDTRONIC SOFAMOR DANEK, INC.
X0213186
In Commercial Distribution

  • 00643169368378 ()


  • Bone file/rasp, manual, reusable
RASP X0213185 7X14X11 WITHOUT STOP
MEDTRONIC SOFAMOR DANEK, INC.
X0213185
In Commercial Distribution

  • 00643169368361 ()


  • Bone file/rasp, manual, reusable
RASP X0213184 6X14X11 WITHOUT STOP
MEDTRONIC SOFAMOR DANEK, INC.
X0213184
In Commercial Distribution

  • 00643169368354 ()


  • Bone file/rasp, manual, reusable
RASP X0213183 5X14X11 WITHOUT STOP
MEDTRONIC SOFAMOR DANEK, INC.
X0213183
In Commercial Distribution

  • 00643169368347 ()


  • Bone file/rasp, manual, reusable
GRIPPER EX0613065 6.35MM ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0613065
In Commercial Distribution

  • 00643169366503 ()


  • Surgical flat-nosed pliers
DRILL GUIDE X0213111 ADJUSTABLE DEPTH
MEDTRONIC SOFAMOR DANEK, INC.
X0213111
In Commercial Distribution

  • 00643169366497 ()


  • Surgical drill guide, reusable
TAP EX0613052 6.5MM SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0613052
In Commercial Distribution

  • 00643169365209 ()


  • Bone tap, reusable
TAP EX0613051 5.5MM SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0613051
In Commercial Distribution

  • 00643169365193 ()


  • Bone tap, reusable
TAP EX0613050 4.5MM SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0613050
In Commercial Distribution

  • 00643169365186 ()


  • Bone tap, reusable
TRIAL 9010000582 ISP CORTICAL WEDGE 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000582
In Commercial Distribution

  • 00643169364974 ()


  • Surgical implant template, reusable
TRIAL 9010000581 ISP CORTICAL WEDGE 14MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000581
In Commercial Distribution

  • 00643169364967 ()


  • Surgical implant template, reusable
TRIAL 9010000580 ISP CORTICAL WEDGE 12MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000580
In Commercial Distribution

  • 00643169364950 ()


  • Surgical implant template, reusable
TRIAL 9010000579 ISP CORTICAL WEDGE 10MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000579
In Commercial Distribution

  • 00643169364943 ()


  • Surgical implant template, reusable
TRIAL 9010000578 ISP CORTICAL WEDGE 8MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000578
In Commercial Distribution

  • 00643169364936 ()


  • Surgical implant template, reusable
TRIAL 9010000575 SUPPLEMENTAL 14MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000575
In Commercial Distribution

  • 00643169364929 ()


  • Surgical implant template, reusable
TRIAL 9010000574 SUPPLEMENTAL 12MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000574
In Commercial Distribution

  • 00643169364912 ()


  • Surgical implant template, reusable
TRIAL 9010000573 SUPPLEMENTAL 10MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000573
In Commercial Distribution

  • 00643169364905 ()


  • Surgical implant template, reusable
INSERTER 9010000570 ISP WEDGE
MEDTRONIC SOFAMOR DANEK, INC.
9010000570
In Commercial Distribution

  • 00643169364875 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
REMOVER EX0313115 SCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX0313115
In Commercial Distribution

  • 00643169364868 ()


  • Orthopaedic implantation sleeve, reusable
DRIVER EX0413085 SETSCREW BREAKOFF
MEDTRONIC SOFAMOR DANEK, INC.
EX0413085
In Commercial Distribution

  • 00643169362833 ()


  • Orthopaedic implant driver
RETRACTOR EX0513002 24MM HAND HELD
MEDTRONIC SOFAMOR DANEK, INC.
EX0513002
In Commercial Distribution

  • 00643169360822 ()


  • Surgical retractor/retraction system blade, reusable
DISTRACTOR X0213194 LEFT HANDED
MEDTRONIC SOFAMOR DANEK, INC.
X0213194
In Commercial Distribution

  • 00643169360280 ()


  • Orthopaedic surgical distractor, internal
TAMP 9010000412 BONE
MEDTRONIC SOFAMOR DANEK, INC.
9010000412
In Commercial Distribution

  • 00643169359024 ()


  • Surgical tamp, reusable
FUNNEL 9010000411 BONE
MEDTRONIC SOFAMOR DANEK, INC.
9010000411
In Commercial Distribution

  • 00643169359017 ()


  • Bone graft funnel
PIN EX0613001 PLATE HOLDING
MEDTRONIC SOFAMOR DANEK, INC.
EX0613001
In Commercial Distribution

  • 00643169358966 ()


  • General internal orthopaedic fixation system implantation kit
SCREWDRIVER EX0313018 SHORT L6.35 MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0313018
In Commercial Distribution

  • 00643169358959 ()


  • Orthopaedic implant driver
FUNNEL EX0413246 GRAFT ASSEMBLY
MEDTRONIC SOFAMOR DANEK, INC.
EX0413246
In Commercial Distribution

  • 00643169358645 ()


  • Bone graft funnel
RETRACTOR EX0513104 TISSUE
MEDTRONIC SOFAMOR DANEK, INC.
EX0513104
In Commercial Distribution

  • 00643169358454 ()


  • Surgical retractor/retraction system blade, reusable
SCREWDRIVER EX0413086 CAPTIVE TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0413086
In Commercial Distribution

  • 00643169358447 ()


  • Orthopaedic implant driver
RETRACTOR EX0513069 TUBULAR 90MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513069
In Commercial Distribution

  • 00643169356726 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513068 TUBULAR 80MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513068
In Commercial Distribution

  • 00643169356719 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513067 TUBULAR 70MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513067
In Commercial Distribution

  • 00643169356702 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513066 TUBULAR 60MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513066
In Commercial Distribution

  • 00643169356696 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513063 TUBULAR 30MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513063
In Commercial Distribution

  • 00643169356689 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513065 TUBULAR 50MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513065
In Commercial Distribution

  • 00643169356672 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513064 TUBULAR 40MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513064
In Commercial Distribution

  • 00643169356665 ()


  • Surgical retractor/retraction system blade, reusable
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