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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DBM T44125INT 5CC GRAFTON ORTHOBLEND LG
MEDTRONIC SOFAMOR DANEK, INC.
T44125INT
In Commercial Distribution

  • 00643169134331 ()

  • 5 cc volume


  • Bone matrix implant, human-derived
DBM T44115INT 15CC GRAFTON CRUNCH
MEDTRONIC SOFAMOR DANEK, INC.
T44115INT
In Commercial Distribution

  • 00643169134324 ()

  • 15cc


  • Bone matrix implant, human-derived
DBM T44105INT 5CC GRAFTON CRUNCH
MEDTRONIC SOFAMOR DANEK, INC.
T44105INT
In Commercial Distribution

  • 00643169134317 ()

  • 5 cc volume


  • Bone matrix implant, human-derived
DBM T43205INT 0.5CC GRAFTON PUTTY SYRNG
MEDTRONIC SOFAMOR DANEK, INC.
T43205INT
In Commercial Distribution

  • 00643169134300 ()

  • 0.5cc


  • Bone matrix implant, human-derived
DBM T43204INT 0.25CC GRAFTON PUTTY SYRNG
MEDTRONIC SOFAMOR DANEK, INC.
T43204INT
In Commercial Distribution

  • 00643169134294 ()

  • 0.25cc


  • Bone matrix implant, human-derived
DBM T43110INT 10CC GRAFTON PUTTY
MEDTRONIC SOFAMOR DANEK, INC.
T43110INT
In Commercial Distribution

  • 00643169134287 ()

  • 10cc


  • Bone matrix implant, human-derived
COMPRESSOR EX1211153 PARALLEL SMALL
MEDTRONIC SOFAMOR DANEK, INC.
EX1211153
In Commercial Distribution

  • 00643169134270 ()


  • Orthopaedic surgical distractor, internal
TAP EX0112175 3.0 TAPERED
MEDTRONIC SOFAMOR DANEK, INC.
EX0112175
In Commercial Distribution

  • 00643169133723 ()


  • Bone tap, reusable
DRILL GUIDE EX0112172 40MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112172
In Commercial Distribution

  • 00643169133419 ()


  • Surgical drill guide, reusable
DRILL GUIDE EX0112171 35MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112171
In Commercial Distribution

  • 00643169133402 ()


  • Surgical drill guide, reusable
DRILL GUIDE EX0112170 30MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112170
In Commercial Distribution

  • 00643169133396 ()


  • Surgical drill guide, reusable
CAGE 2964444 CAPSTONE-L 6 DEG 14X44
MEDTRONIC SOFAMOR DANEK, INC.
2964444
Not in Commercial Distribution

  • 00643169133334 ()

  • 6 DEG, 14 MM X 44 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964836 CAPSTONE-L 6 DEG 8X36
MEDTRONIC SOFAMOR DANEK, INC.
2964836
Not in Commercial Distribution

  • 00643169133198 ()

  • 6 DEG, 8 MM X 36 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964840 CAPSTONE-L 6 DEG 8X40
MEDTRONIC SOFAMOR DANEK, INC.
2964840
Not in Commercial Distribution

  • 00643169133181 ()

  • 6 DEG, 8 MM X 40 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964844 CAPSTONE-L 6 DEG 8X44
MEDTRONIC SOFAMOR DANEK, INC.
2964844
Not in Commercial Distribution

  • 00643169133174 ()

  • 6 DEG, 8 MM X 44 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964036 CAPSTONE-L 6 DEG 10X36
MEDTRONIC SOFAMOR DANEK, INC.
2964036
In Commercial Distribution

  • 00643169133112 ()

  • 6 DEG, 10 MM X 36 MM


  • Polymeric spinal interbody fusion cage
CAGE 2964040 CAPSTONE-L 6 DEG 10X40
MEDTRONIC SOFAMOR DANEK, INC.
2964040
Not in Commercial Distribution

  • 00643169133105 ()

  • 6 DEG, 10 MM X 40 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964044 CAPSTONE-L 6 DEG 10X44
MEDTRONIC SOFAMOR DANEK, INC.
2964044
Not in Commercial Distribution

  • 00643169133099 ()

  • 6 DEG, 10 MM X 44 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964236 CAPSTONE-L 6 DEG 12X36
MEDTRONIC SOFAMOR DANEK, INC.
2964236
Not in Commercial Distribution

  • 00643169133037 ()

  • 6 DEG, 12 MM X 36 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964240 CAPSTONE-L 6 DEG 12X40
MEDTRONIC SOFAMOR DANEK, INC.
2964240
Not in Commercial Distribution

  • 00643169133020 ()

  • 6 DEG, 12 MM X 40 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964244 CAPSTONE-L 6 DEG 12X44
MEDTRONIC SOFAMOR DANEK, INC.
2964244
Not in Commercial Distribution

  • 00643169133013 ()

  • 6 DEG, 12 MM X 44 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964436 CAPSTONE-L 6 DEG 14X36
MEDTRONIC SOFAMOR DANEK, INC.
2964436
Not in Commercial Distribution

  • 00643169132955 ()

  • 6 DEG, 14 MM X 36 MM


  • Polymeric spinal fusion cage, sterile
CAGE 2964440 CAPSTONE-L 6 DEG 14X40
MEDTRONIC SOFAMOR DANEK, INC.
2964440
Not in Commercial Distribution

  • 00643169132948 ()

  • 6 DEG, 14 MM X 40 MM


  • Polymeric spinal fusion cage, sterile
SPACER 1-3206 US 6MM X-STOP PEEK
MEDTRONIC SOFAMOR DANEK, INC.
1-3206
In Commercial Distribution

  • 00643169132856 ()

  • Minor Diameter 6mm


  • Lumbar decompression interspinous spacer
SPACER 1-3208 US 8MM X-STOP PEEK
MEDTRONIC SOFAMOR DANEK, INC.
1-3208
In Commercial Distribution

  • 00643169132849 ()

  • Minor Diameter 8mm


  • Lumbar decompression interspinous spacer
SPACER 1-3210 US 10MM X-STOP PEEK
MEDTRONIC SOFAMOR DANEK, INC.
1-3210
In Commercial Distribution

  • 00643169132832 ()

  • Minor Diameter 10mm


  • Lumbar decompression interspinous spacer
SPACER 1-3212 US 12MM X-STOP PEEK
MEDTRONIC SOFAMOR DANEK, INC.
1-3212
In Commercial Distribution

  • 00643169132825 ()

  • Minor Diameter 12mm


  • Lumbar decompression interspinous spacer
SPACER 1-3214 US 14MM X-STOP PEEK
MEDTRONIC SOFAMOR DANEK, INC.
1-3214
In Commercial Distribution

  • 00643169132818 ()

  • Minor Diameter 14mm


  • Lumbar decompression interspinous spacer
SPACER 1-3216 US 16MM X-STOP PEEK
MEDTRONIC SOFAMOR DANEK, INC.
1-3216
In Commercial Distribution

  • 00643169132801 ()

  • Minor Diameter 16mm


  • Lumbar decompression interspinous spacer
SPACER 1-2206 US 6MM X-STOP
MEDTRONIC SOFAMOR DANEK, INC.
1-2206
In Commercial Distribution

  • 00643169132740 ()

  • Minor Diameter 6mm


  • Lumbar decompression interspinous spacer
SPACER 1-2208 US 8MM X-STOP
MEDTRONIC SOFAMOR DANEK, INC.
1-2208
Not in Commercial Distribution

  • 00643169132733 ()

  • Minor Diameter 8mm


  • Lumbar decompression interspinous spacer
SPACER 1-2210 US 10MM X-STOP
MEDTRONIC SOFAMOR DANEK, INC.
1-2210
In Commercial Distribution

  • 00643169132726 ()

  • Minor Diameter 10mm


  • Lumbar decompression interspinous spacer
SPACER 1-2212 US 12MM X-STOP
MEDTRONIC SOFAMOR DANEK, INC.
1-2212
In Commercial Distribution

  • 00643169132719 ()

  • Minor Diameter 12mm


  • Lumbar decompression interspinous spacer
SPACER 1-2214 US 14MM X-STOP
MEDTRONIC SOFAMOR DANEK, INC.
1-2214
In Commercial Distribution

  • 00643169132702 ()

  • Minor Diameter 14mm


  • Lumbar decompression interspinous spacer
DELIVERY TUBE EX0112165 MED 30 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0112165
In Commercial Distribution

  • 00643169132504 ()


  • Bone graft funnel
DELIVERY TUBE EX0112163 SM 30 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0112163
In Commercial Distribution

  • 00643169132481 ()


  • Bone graft funnel
DELIVERY TUBE EX0112162 SM 15 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0112162
In Commercial Distribution

  • 00643169132474 ()


  • Bone graft funnel
DRILL EX0112146 3.5 MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112146
In Commercial Distribution

  • 00643169132443 ()


  • Fluted surgical drill bit, reusable
GUIDE EX0112144 ADJ DRILL
MEDTRONIC SOFAMOR DANEK, INC.
EX0112144
In Commercial Distribution

  • 00643169132429 ()


  • Surgical drill guide, reusable
DRILL EX0112143 1.5 MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112143
In Commercial Distribution

  • 00643169132412 ()


  • Fluted surgical drill bit, reusable
SCRAPER EX1211048 PUSH
MEDTRONIC SOFAMOR DANEK, INC.
EX1211048
In Commercial Distribution

  • 00643169132405 ()


  • Orthopaedic knife
CURETTE EX1211017 LARGE FORWARD ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1211017
In Commercial Distribution

  • 00643169132399 ()


  • Bone curette, reusable
CURETTE EX1211016 LARGE REVERSE ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1211016
In Commercial Distribution

  • 00643169132382 ()


  • Bone curette, reusable
SCREWDRIVER EX1211015 0 DEG ILIO SACRAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1211015
In Commercial Distribution

  • 00643169132375 ()


  • Surgical screwdriver, reusable
REMOVER EX1111156 SCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX1111156
In Commercial Distribution

  • 00643169132269 ()


  • Surgical screwdriver, reusable
GUIDE EX0112054 DUAL DRILLING
MEDTRONIC SOFAMOR DANEK, INC.
EX0112054
In Commercial Distribution

  • 00643169123304 ()


  • Surgical drill guide, reusable
HOLDER EX1211203 3.2MM ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1211203
In Commercial Distribution

  • 00643169123298 ()


  • Surgical implant/trial-implant/sizer holder, reusable
SPREADER EX1011195 MEASURING HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1011195
In Commercial Distribution

  • 00643169123229 ()


  • Surgical instrument handle, non-torque-limiting
AWL EX1211167 ROUND AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX1211167
In Commercial Distribution

  • 00643169123212 ()


  • Bone awl, reusable
AWL EX1211166 SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX1211166
In Commercial Distribution

  • 00643169123205 ()


  • Bone awl, reusable
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