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 2981522 CAPSTONE 15 X 22MM
MEDTRONIC SOFAMOR DANEK, INC.
2981522
In Commercial Distribution

  • 00613994806086 ()


  • Spinal implant trial
TRIAL 2981336 CAPSTONE 13 X 36MM
MEDTRONIC SOFAMOR DANEK, INC.
2981336
In Commercial Distribution

  • 00613994806079 ()


  • Spinal implant trial
TRIAL 2981332 CAPSTONE 13 X 32MM
MEDTRONIC SOFAMOR DANEK, INC.
2981332
In Commercial Distribution

  • 00613994806062 ()


  • Spinal implant trial
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
BENDER 5484316 CORONAL - RIGHT 4.75
MEDTRONIC SOFAMOR DANEK, INC.
5484316
In Commercial Distribution

  • 00613994761538 ()


  • Manual orthopaedic bender, reusable
TRANSLATOR 5484310 RIGHT 4.75
MEDTRONIC SOFAMOR DANEK, INC.
5484310
In Commercial Distribution

  • 00613994761484 ()


  • Orthopaedic fixation implant alignment tool
CURETTE EX0210156 NON-BAYONETED L ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0210156
In Commercial Distribution

  • 00613994764409 ()


  • Bone curette, reusable
CURETTE EX0210155 NON-BAYONETED R ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0210155
In Commercial Distribution

  • 00613994764393 ()


  • Bone curette, reusable
CURETTE EX0210154 NON-BAYONETED STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0210154
In Commercial Distribution

  • 00613994764386 ()


  • Bone curette, reusable
BENDER 5484313 INSITU - LEFT 4.75
MEDTRONIC SOFAMOR DANEK, INC.
5484313
In Commercial Distribution

  • 00613994761576 ()


  • Manual orthopaedic bender, reusable
BENDER 5484315 CORONAL - LEFT 4.75
MEDTRONIC SOFAMOR DANEK, INC.
5484315
In Commercial Distribution

  • 00613994761521 ()


  • Manual orthopaedic bender, reusable
TAMP EX0210043 BONE
MEDTRONIC SOFAMOR DANEK, INC.
EX0210043
In Commercial Distribution

  • 00613994761163 ()


  • Surgical tamp, reusable
FUNNEL EX0210042 BONE
MEDTRONIC SOFAMOR DANEK, INC.
EX0210042
In Commercial Distribution

  • 00613994761156 ()


  • Bone graft funnel
AWL X0816047 BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0816047
In Commercial Distribution

  • 00643169885578 ()


  • Bone awl, reusable
SCREWDRIVR X0816101 XTR LNG MAS LCK SLVE
MEDTRONIC SOFAMOR DANEK, INC.
X0816101
In Commercial Distribution

  • 00643169883321 ()


  • General internal orthopaedic fixation system implantation kit
BENDER EX0816026 IN-SITU LONG RGHT 5.5/6
MEDTRONIC SOFAMOR DANEK, INC.
EX0816026
In Commercial Distribution

  • 00643169880283 ()


  • Manual orthopaedic bender, reusable
BENDER EX0816025 IN-SITU LONG LEFT 5.5/6
MEDTRONIC SOFAMOR DANEK, INC.
EX0816025
In Commercial Distribution

  • 00643169880276 ()


  • Manual orthopaedic bender, reusable
PROBE EX0916015 CANNULATED ILIAC
MEDTRONIC SOFAMOR DANEK, INC.
EX0916015
In Commercial Distribution

  • 00643169880252 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
SHAVER EX1016011 TRIANGLE 30
MEDTRONIC SOFAMOR DANEK, INC.
EX1016011
In Commercial Distribution

  • 00643169878297 ()


  • Orthopaedic knife
EXTRACTOR EX0216073 SCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX0216073
In Commercial Distribution

  • 00643169873995 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
PROBE EX0916092 EXTENDED BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0916092
In Commercial Distribution

  • 00643169873988 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
TUBE EX0616066 16/7 ALUMINIUM METRX
MEDTRONIC SOFAMOR DANEK, INC.
EX0616066
In Commercial Distribution

  • 00643169872165 ()


  • Hand-held surgical retractor, reusable
WRENCH X0816076 ROTATION STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0816076
In Commercial Distribution

  • 00643169871533 ()


  • Surgical torque wrench, reusable
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