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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Driver, Height Adjustment Size 25
K2M, INC.
PRO-1378
In Commercial Distribution

  • 10888857579637 ()
PRO-1378

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Screwdriver, Split Tip
K2M, INC.
PRO-1330
In Commercial Distribution

  • 10888857563254 ()
PRO-1330

  • Surgical screwdriver, reusable
Flex Shaft Tapered Driver Size 20
K2M, INC.
PRO-1218
In Commercial Distribution

  • 10888857561595 ()
PRO-1218

  • Surgical screwdriver, reusable
Self Retaining Screw Inserter
K2M, INC.
PRO-1318
In Commercial Distribution

  • 10888857561373 ()
PRO-1318

  • Orthopaedic implant driver
SAFIRA System hand operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Palm Operator
In Commercial Distribution

  • 05060727270068 ()
900059

  • Pain management medication delivery system
SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA operators and SAFIRA Syringes
MEDOVATE LIMITED
SAFIRA Driver
In Commercial Distribution

  • 05060727270020 ()
900029

  • Pain management medication delivery system
SAFIRA system foot operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Foot Pedal
In Commercial Distribution

  • 05060727270013 ()
900044

  • Pain management medication delivery system
DRIVER 2300000LO POWEREASE LOANER
MEDTRONIC SOFAMOR DANEK, INC.
2300000LO
In Commercial Distribution

  • 00643169552999 ()


  • Surgical screwdriver, reusable
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000953 ()
Reconstruction Planner

  • CAD/CAM software
Materialise Mimics Enlight CMF Orthognathic and Trauma Planner
Materialise NV
Orthognathic and Trauma Planner
In Commercial Distribution

  • 05404028000946 ()
Orthognathic and Trauma Planner

  • CAD/CAM software
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000816 ()
Reconstruction Planner

  • CAD/CAM software
Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
DRIVER 4360520 T17 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
4360520
In Commercial Distribution

  • 00643169601130 ()


  • Surgical screwdriver, reusable
DRIVER 4360513 T10 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
4360513
In Commercial Distribution

  • 00643169601123 ()


  • Surgical screwdriver, reusable
DRIVER 8001201 HANDL MOD TIMESH
MEDTRONIC PS MEDICAL, INC.
8001201
In Commercial Distribution

  • 00643169497870 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER 8001205 MOD SHAFT 1.6MM
MEDTRONIC PS MEDICAL, INC.
8001205
In Commercial Distribution

  • 00643169497863 ()

  • Outer Diameter: 1.6 Millimeter


  • General internal orthopaedic fixation system implantation kit
DRIVER X0914030 FLEX ARM NUT
MEDTRONIC SOFAMOR DANEK, INC.
X0914030
In Commercial Distribution

  • 00643169549241 ()


  • General internal orthopaedic fixation system implantation kit
TRAY NAV2030 NAV DRIVERS AND TAPS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2030
In Commercial Distribution

  • 00643169546240 ()


  • Instrument tray, reusable
DRIVER NAV2024K SOLERA 4.75 STANDARD MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2024K
In Commercial Distribution

  • 00643169545854 ()

  • Outer Diameter: 4.75 Millimeter


  • Surgical screwdriver, reusable
DRIVER NAV2023K SOLERA 4.75 MAS LG2
MEDTRONIC SOFAMOR DANEK, INC.
NAV2023K
In Commercial Distribution

  • 00643169545847 ()

  • Outer Diameter: 4.75 Millimeter


  • Surgical screwdriver, reusable
DRIVER NAV2022K SOLERA 5.5/6 FAS/SAS LG2
MEDTRONIC SOFAMOR DANEK, INC.
NAV2022K
In Commercial Distribution

  • 00643169545830 ()

  • Width: 5.5 Millimeter
  • Width: 6.0 Millimeter


  • Surgical screwdriver, reusable
DRIVER NAV2021K SOLERA 5.5/6 FAS/SAS LG
MEDTRONIC SOFAMOR DANEK, INC.
NAV2021K
In Commercial Distribution

  • 00643169545823 ()

  • Width: 6.0 Millimeter
  • Width: 5.5 Millimeter


  • Surgical screwdriver, reusable
DRIVER NAV2020K SOLERA 5.5/6 MAS LG2
MEDTRONIC SOFAMOR DANEK, INC.
NAV2020K
In Commercial Distribution

  • 00643169545816 ()

  • Width: 5.5 Millimeter
  • Width: 6.0 Millimeter


  • Surgical screwdriver, reusable
DRIVER NAV2019K SOLERA 5.5/6 MAS LG
MEDTRONIC SOFAMOR DANEK, INC.
NAV2019K
In Commercial Distribution

  • 00643169545809 ()

  • Width: 6.0 Millimeter
  • Width: 5.5 Millimeter


  • Surgical screwdriver, reusable
DRIVER X0814002 T25 QC THK SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0814002
In Commercial Distribution

  • 00643169541375 ()


  • Orthopaedic implant driver
PIN X0514003 PLATE HOLDING
MEDTRONIC SOFAMOR DANEK, INC.
X0514003
In Commercial Distribution

  • 00643169541351 ()


  • External spinal fixation system
DRIVER 9735253K T-HANDLE 5MM HEX KIT
MEDTRONIC NAVIGATION, INC.
9735253K
In Commercial Distribution

  • 00643169540552 ()

  • 5mm


  • Multi-purpose stereotactic surgery system
DRIVER EX0614091 T-25 330 LG SLR HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0614091
Not in Commercial Distribution

  • 00643169513792 ()


  • Orthopaedic implant driver
DRIVER EX0514021 TAPERED HEX 3.2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0514021
In Commercial Distribution

  • 00643169523562 ()


  • Orthopaedic implant driver
DRIVER EX1114022 T27 REDUCTION SCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX1114022
In Commercial Distribution

  • 00643169566125 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX1014067 FAS LOCK SLEEVE SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX1014067
In Commercial Distribution

  • 00643169566118 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX1014054 5.5/6.0 MAS LCK SLV
MEDTRONIC SOFAMOR DANEK, INC.
EX1014054
In Commercial Distribution

  • 00643169566088 ()


  • Orthopaedic implant driver
DRIVER X1014014 PED MARKER BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1014014
In Commercial Distribution

  • 00643169557376 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX0814038 CANN. THREADED SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0814038
In Commercial Distribution

  • 00643169553811 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER NAV2025K SOLERA 4.75 REDUCT MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2025K
In Commercial Distribution

  • 00643169545861 ()

  • Outer Diameter: 4.75 Millimeter


  • Surgical screwdriver, reusable
Insertion Handle - Large
Neoss AB
51191
In Commercial Distribution

  • 05060440335754 ()
51191

  • Surgical screwdriver, reusable
DRIVER 6640005 4.75 NON-RETAINING DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6640005
In Commercial Distribution

  • 00643169492516 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER 6640004 4.75 BALL-ENDED DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6640004
In Commercial Distribution

  • 00643169492509 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER 6640008 4.75 SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6640008
In Commercial Distribution

  • 00643169492493 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER 6642002 4.75 SET SCRW RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
6642002
In Commercial Distribution

  • 00643169492455 ()


  • General internal orthopaedic fixation system implantation kit
iGO Screwdriver, Machine 32mm
Neoss AB
51184
In Commercial Distribution

  • 05060440333583 ()
51184

  • Surgical screwdriver, reusable
iGO Screwdriver, Machine 22mm
Neoss AB
51183
In Commercial Distribution

  • 05060440333576 ()
51183

  • Surgical screwdriver, reusable
Implant Inserter, NP 24 mm
Neoss AB
51145
In Commercial Distribution

  • 05060440332647 ()
51145

  • Surgical screwdriver, reusable
Wrench Adapter
Neoss AB
51144
In Commercial Distribution

  • 05060440332630 ()
51144

  • Surgical screwdriver, reusable
Neo Screwdriver, Manual 15mm
Neoss AB
51141
In Commercial Distribution

  • 05060440332616 ()
51141

  • Surgical screwdriver, reusable
Neo Screwdriver, Machine 32mm
Neoss AB
51140
In Commercial Distribution

  • 05060440332609 ()
51140

  • Surgical screwdriver, reusable
Implant Inserter, SP 17 mm
Neoss AB
51137
In Commercial Distribution

  • 05060440332586 ()
51137

  • Surgical screwdriver, reusable
Surgical Instrument Kit
Neoss AB
41151
In Commercial Distribution

  • 05060440332494 ()
41151

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
  • Surgical screwdriver, reusable
DRIVER X0513076 EXTENDED
MEDTRONIC SOFAMOR DANEK, INC.
X0513076
In Commercial Distribution

  • 00643169482210 ()


  • Orthopaedic implant driver
Universal Driver, Size 20
K2M, INC.
PRO-1020
In Commercial Distribution

  • 10888857516984 ()

  • Size 20 Hexalobe
PRO-1020

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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