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 X0420011 16DEG 12MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420011
In Commercial Distribution

  • 00763000940430 ()


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

  • 00763000940416 ()


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

  • 00763000940393 ()


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

  • 00763000940379 ()


  • Spinal implant trial
REFERENCE X0723001 ROD 5.5/6.0 SHORT
MEDTRONIC SOFAMOR DANEK, INC.
X0723001
In Commercial Distribution

  • 00763000920036 ()


  • Surgical implant template, reusable
ROD FRAME X0423002 5.5MM SHORT
MEDTRONIC SOFAMOR DANEK, INC.
X0423002
In Commercial Distribution

  • 00763000920029 ()


  • 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
SCREWDRIVER EX0923003 UCSS FLEX SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0923003
In Commercial Distribution

  • 00763000918040 ()


  • Surgical screwdriver, reusable
BENDER EX1023002 5.5/6.0MM SAGITTAL ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1023002
In Commercial Distribution

  • 00763000917999 ()


  • Manual orthopaedic bender, reusable
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
RETRACTOR EX0823280 80MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823280
In Commercial Distribution

  • 00763000913977 ()


  • 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 EX0823170 70MM MIS OBG TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0823170
In Commercial Distribution

  • 00763000913939 ()


  • 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
BLADE X07317191 SLIM CC L 190MM
MEDTRONIC SOFAMOR DANEK, INC.
X07317191
In Commercial Distribution

  • 00763000897185 ()


  • Surgical retraction system, reusable
BLADE X07317172 SLIM LT 170MM
MEDTRONIC SOFAMOR DANEK, INC.
X07317172
In Commercial Distribution

  • 00763000897161 ()


  • Surgical retraction system, reusable
BLADE X07317171 SLIM CC L 170MM
MEDTRONIC SOFAMOR DANEK, INC.
X07317171
In Commercial Distribution

  • 00763000897154 ()


  • Surgical retraction system, reusable
BLADE X07317170 SLIM CC R 170MM
MEDTRONIC SOFAMOR DANEK, INC.
X07317170
In Commercial Distribution

  • 00763000897147 ()


  • Surgical retraction system, reusable
BLADE X07317152 SLIM LT 150MM
MEDTRONIC SOFAMOR DANEK, INC.
X07317152
In Commercial Distribution

  • 00763000897130 ()


  • Surgical retraction system, reusable
BLADE X07317150 SLIM CC R 150MM
MEDTRONIC SOFAMOR DANEK, INC.
X07317150
In Commercial Distribution

  • 00763000897116 ()


  • Surgical retraction system, reusable
BLADE X07317131 SLIM CC L 130MM
MEDTRONIC SOFAMOR DANEK, INC.
X07317131
In Commercial Distribution

  • 00763000897093 ()


  • Surgical retraction system, reusable
BLADE X07317110 SLIM CC R 110MM
MEDTRONIC SOFAMOR DANEK, INC.
X07317110
In Commercial Distribution

  • 00763000897055 ()


  • Surgical retraction system, reusable
BLADE X07317090 SLIM CC R 90MM
MEDTRONIC SOFAMOR DANEK, INC.
X07317090
In Commercial Distribution

  • 00763000897024 ()


  • Surgical retraction system, reusable
TRIAL X0420046 24DEG 16MM X-LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420046
In Commercial Distribution

  • 00763000940782 ()


  • Spinal implant trial
TRIAL X0420045 24DEG 14MM X-LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420045
In Commercial Distribution

  • 00763000940775 ()


  • Spinal implant trial
TRIAL X0420044 24DEG 20MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420044
In Commercial Distribution

  • 00763000940768 ()


  • Spinal implant trial
TRIAL X0420043 24DEG 18MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420043
In Commercial Distribution

  • 00763000940751 ()


  • Spinal implant trial
TRIAL X0420040 24DEG 20MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420040
In Commercial Distribution

  • 00763000940720 ()


  • Spinal implant trial
TRIAL X0420037 24DEG 14MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420037
In Commercial Distribution

  • 00763000940690 ()


  • Spinal implant trial
TRIAL X0420036 20DEG 20MM X-LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420036
In Commercial Distribution

  • 00763000940683 ()


  • Spinal implant trial
TRIAL X0420034 20DEG 16MM X-LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420034
In Commercial Distribution

  • 00763000940669 ()


  • Spinal implant trial
TRIAL X0420033 20DEG 14MM X-LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420033
In Commercial Distribution

  • 00763000940652 ()


  • Spinal implant trial
TRIAL X0420031 20DEG 20MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420031
In Commercial Distribution

  • 00763000940638 ()


  • Spinal implant trial
TRIAL X0420028 20DEG 14MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420028
In Commercial Distribution

  • 00763000940607 ()


  • Spinal implant trial
TRIAL X0420026 20DEG 20MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420026
In Commercial Distribution

  • 00763000940584 ()


  • Spinal implant trial
TRIAL X0420024 20DEG 16MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420024
In Commercial Distribution

  • 00763000940560 ()


  • Spinal implant trial
TRIAL X0420022 20DEG 12MM STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
X0420022
In Commercial Distribution

  • 00763000940546 ()


  • Spinal implant trial
TRIAL X0420019 16DEG 16MM X-LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420019
In Commercial Distribution

  • 00763000940515 ()


  • Spinal implant trial
TRIAL X0420018 16DEG 14MM X-LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420018
In Commercial Distribution

  • 00763000940508 ()


  • Spinal implant trial
TRIAL X0420015 16DEG 20MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420015
In Commercial Distribution

  • 00763000940478 ()


  • Spinal implant trial
TRIAL X0420014 16DEG 18MM LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0420014
In Commercial Distribution

  • 00763000940461 ()


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

  • 00763000940423 ()


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

  • 00763000940409 ()


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

  • 00763000940386 ()


  • 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
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