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 2981326 CAPSTONE 13 X 26MM
MEDTRONIC SOFAMOR DANEK, INC.
2981326
In Commercial Distribution

  • 00613994806055 ()


  • Spinal implant trial
TRIAL 2981322 CAPSTONE 13 X 22MM
MEDTRONIC SOFAMOR DANEK, INC.
2981322
In Commercial Distribution

  • 00613994806048 ()


  • Spinal implant trial
TRIAL 2981136 CAPSTONE 11 X 36MM
MEDTRONIC SOFAMOR DANEK, INC.
2981136
In Commercial Distribution

  • 00613994806031 ()


  • Spinal implant trial
TRIAL 2981132 CAPSTONE 11 X 32MM
MEDTRONIC SOFAMOR DANEK, INC.
2981132
In Commercial Distribution

  • 00613994806024 ()


  • Spinal implant trial
TAP EX0510275 8.5 SOLID DUAL START
MEDTRONIC SOFAMOR DANEK, INC.
EX0510275
In Commercial Distribution

  • 00613994806017 ()


  • Bone tap, reusable
TAP EX0510274 7.5 SOLID DUAL START
MEDTRONIC SOFAMOR DANEK, INC.
EX0510274
In Commercial Distribution

  • 00613994806000 ()


  • Bone tap, reusable
TAP EX0510273 6.5 SOLID DUAL START
MEDTRONIC SOFAMOR DANEK, INC.
EX0510273
In Commercial Distribution

  • 00613994805997 ()


  • Bone tap, reusable
TAP EX0510272 6.0 SOLID DUAL START
MEDTRONIC SOFAMOR DANEK, INC.
EX0510272
In Commercial Distribution

  • 00613994805980 ()


  • Bone tap, reusable
TAP EX0510271 5.5 SOLID DUAL START
MEDTRONIC SOFAMOR DANEK, INC.
EX0510271
In Commercial Distribution

  • 00613994805973 ()


  • Bone tap, reusable
TAP EX0510270 5.0 SOLID DUAL START
MEDTRONIC SOFAMOR DANEK, INC.
EX0510270
In Commercial Distribution

  • 00613994805966 ()


  • Bone tap, reusable
TAP EX0510269 4.5 SOLID DUAL START
MEDTRONIC SOFAMOR DANEK, INC.
EX0510269
In Commercial Distribution

  • 00613994805959 ()


  • Bone tap, reusable
TAP EX0510268 4.0 SOLID DUAL START
MEDTRONIC SOFAMOR DANEK, INC.
EX0510268
In Commercial Distribution

  • 00613994805942 ()


  • Bone tap, reusable
TAP EX0510267 3.75 SOLID DUAL START
MEDTRONIC SOFAMOR DANEK, INC.
EX0510267
In Commercial Distribution

  • 00613994805935 ()


  • Bone tap, reusable
INSERTER 2990001 THREADED
MEDTRONIC SOFAMOR DANEK, INC.
2990001
In Commercial Distribution

  • 00613994803061 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
CALIPER 5484329 X10 CALIPER
MEDTRONIC SOFAMOR DANEK, INC.
5484329
In Commercial Distribution

  • 00613994798022 ()


  • General-purpose calliper, metallic
INSERTER X1109202 10 DEGREE ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
X1109202
Not in Commercial Distribution

  • 00613994795786 ()


  • Orthopaedic graft inserter, reusable
COUNTER TORQUE EX0410070 L-HANDLE 3.5
MEDTRONIC SOFAMOR DANEK, INC.
EX0410070
In Commercial Distribution

  • 00613994790736 ()


  • Orthopaedic counter-torque/rod-pushing instrument
OSTEOTOME X0410082 ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
X0410082
In Commercial Distribution

  • 00613994789785 ()


  • Orthopaedic osteotome
HOLDER 2942017 XPAK DILATOR HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
2942017
In Commercial Distribution

  • 00613994866707 ()


  • Surgical implant/trial-implant/sizer holder, reusable
GRAFT IMPACTOR X0810801 BONE
MEDTRONIC SOFAMOR DANEK, INC.
X0810801
In Commercial Distribution

  • 00613994866059 ()


  • Orthopaedic implant impactor, reusable
DRIVER T27 X0810812 NON BRK OFF QC X 290
MEDTRONIC SOFAMOR DANEK, INC.
X0810812
In Commercial Distribution

  • 00613994866035 ()


  • Surgical drill guide, reusable
DRIVER T27 X0810811 NON BRK OFF QC X 155
MEDTRONIC SOFAMOR DANEK, INC.
X0810811
In Commercial Distribution

  • 00613994866028 ()


  • Surgical drill guide, reusable
DRIVER T27 X0810810 REDUCTION QC X 290
MEDTRONIC SOFAMOR DANEK, INC.
X0810810
In Commercial Distribution

  • 00613994866011 ()


  • Surgical drill guide, reusable
DRIVER T27 X0810809 REDUCTION QC X 155
MEDTRONIC SOFAMOR DANEK, INC.
X0810809
In Commercial Distribution

  • 00613994866004 ()


  • Surgical drill guide, reusable
DRIVER EX0710385 LOCKABLE MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0710385
In Commercial Distribution

  • 00613994862464 ()


  • Orthopaedic implant driver
6.35 DRIVER EX0810680 SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810680
Not in Commercial Distribution

  • 00613994862402 ()


  • Surgical drill guide, reusable
TEMPLATE EX0610160 SCREW PLACEMENT
MEDTRONIC SOFAMOR DANEK, INC.
EX0610160
In Commercial Distribution

  • 00613994860576 ()


  • Surgical implant template, reusable
STARTER EX0610281 T27 NON BREAKOFF PLUG
MEDTRONIC SOFAMOR DANEK, INC.
EX0610281
In Commercial Distribution

  • 00613994860552 ()


  • General internal orthopaedic fixation system implantation kit
COUNTERTORQUE EX0810504 5.5 WITH WINDOW
MEDTRONIC SOFAMOR DANEK, INC.
EX0810504
In Commercial Distribution

  • 00613994860545 ()


  • Orthopaedic counter-torque/rod-pushing instrument
HOLDER EX0610121 PLATE
MEDTRONIC SOFAMOR DANEK, INC.
EX0610121
In Commercial Distribution

  • 00613994860538 ()


  • Surgical implant/trial-implant/sizer holder, reusable
BLADE EX0710389 6 CM M/L BLADE
MEDTRONIC SOFAMOR DANEK, INC.
EX0710389
In Commercial Distribution

  • 00613994860521 ()


  • Orthopaedic knife
BLADE EX0710388 5 CM M/L BLADE
MEDTRONIC SOFAMOR DANEK, INC.
EX0710388
In Commercial Distribution

  • 00613994860514 ()


  • Orthopaedic knife
BLADE EX0710387 4 CM M/L BLADE
MEDTRONIC SOFAMOR DANEK, INC.
EX0710387
In Commercial Distribution

  • 00613994860507 ()


  • Orthopaedic knife
BLADE EX0710386 3 CM M/L BLADE
MEDTRONIC SOFAMOR DANEK, INC.
EX0710386
In Commercial Distribution

  • 00613994860491 ()


  • Orthopaedic knife
RETRACTOR EX07101315 WIDE NERVE ROOT
MEDTRONIC SOFAMOR DANEK, INC.
EX07101315
In Commercial Distribution

  • 00613994860484 ()


  • Surgical retractor/retraction system blade, reusable
DISSECTOR EX0510016 TIP 8MMX1.35MMX58MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0510016
In Commercial Distribution

  • 00613994860460 ()


  • Open-surgery dissector
ROD REDUCER EX0610090 3.5 SCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX0610090
In Commercial Distribution

  • 00613994860453 ()


  • Orthopaedic rod reducer
CORONAL BENDER EX0810463 6.35 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810463
In Commercial Distribution

  • 00613994860422 ()


  • Manual orthopaedic bender, reusable
CORONAL BENDER EX0810462 6.35 LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810462
In Commercial Distribution

  • 00613994860415 ()


  • Manual orthopaedic bender, reusable
CORONAL BENDER EX0810461 5.5 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810461
In Commercial Distribution

  • 00613994860408 ()


  • Manual orthopaedic bender, reusable
CORONAL BENDER EX0810460 5.5 LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810460
In Commercial Distribution

  • 00613994860392 ()


  • Manual orthopaedic bender, reusable
COUNTERTORQUE EX0810503 6.35 WITH WINDOW
MEDTRONIC SOFAMOR DANEK, INC.
EX0810503
In Commercial Distribution

  • 00613994860385 ()


  • Orthopaedic counter-torque/rod-pushing instrument
BENDER EX0810459 6.35 IN-SITU RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810459
In Commercial Distribution

  • 00613994860095 ()


  • Manual orthopaedic bender, reusable
BENDER EX0810458 6.35 IN-SITU LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810458
In Commercial Distribution

  • 00613994860088 ()


  • Manual orthopaedic bender, reusable
TROCAR EX0610119 BEVEL TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0610119
In Commercial Distribution

  • 00613994860071 ()


  • Orthopaedic trocar blade, reusable
DRILL GUIDE EX0610117 BAYONET
MEDTRONIC SOFAMOR DANEK, INC.
EX0610117
In Commercial Distribution

  • 00613994860064 ()


  • Surgical drill guide, reusable
BAR EX0810586 STABILIZATION
MEDTRONIC SOFAMOR DANEK, INC.
EX0810586
In Commercial Distribution

  • 00613994858283 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
BAR EX0810496 TRANSVERSE LOCKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0810496
In Commercial Distribution

  • 00613994858276 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
MOUNT EX0810495 STABILIZATION
MEDTRONIC SOFAMOR DANEK, INC.
EX0810495
In Commercial Distribution

  • 00613994858269 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
BLADE EX0710008 LP DL 17CM RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0710008
In Commercial Distribution

  • 00613994853806 ()


  • Orthopaedic knife
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