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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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Medtronic Reusable Instruments - 00643169362833

DRIVER EX0413085 SETSCREW BREAKOFF
MEDTRONIC SOFAMOR DANEK, INC.
EX0413085
In Commercial Distribution

  • 00643169362833 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169358959

SCREWDRIVER EX0313018 SHORT L6.35 MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0313018
In Commercial Distribution

  • 00643169358959 ()


  • Orthopaedic implant driver

RAVINE™ Access System - 10888857427365

ACDF Pin Driver
K2M, INC.
2701-90235
In Commercial Distribution

  • 10888857427365 ()
2701-90235

  • Bone nail driver

Medtronic Reusable Instruments - 00643169408289

MAS DRIVER EX0913068 RETAIN. BONESCR.T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0913068
In Commercial Distribution

  • 00643169408289 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169398788

DRIVER EX0713173 T-25 TAPERED
MEDTRONIC SOFAMOR DANEK, INC.
EX0713173
In Commercial Distribution

  • 00643169398788 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169383135

DRIVER X0513072 GECKO
MEDTRONIC SOFAMOR DANEK, INC.
X0513072
In Commercial Distribution

  • 00643169383135 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169376502

DRIVER X0613077 2.5MM HEX CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
X0613077
In Commercial Distribution

  • 00643169376502 ()


  • Orthopaedic implant driver

Infinity-Lock Button System - 05060267131836

No Description
XIROS LTD
102-1089
In Commercial Distribution

  • 05060267131836 ()
n/a

  • Acromioclavicular joint stabilization implant
  • Cannulated surgical drill bit, single-use

Impactor Assembly - 05060267130785

No Description
XIROS LTD
202-1137
In Commercial Distribution

  • 05060267130785 ()
n/a

  • Orthopaedic inorganic implant inserter/extractor, reusable

Medtronic Reusable Instruments - 00643169408524

DRIVER 9010000510 T27
MEDTRONIC SOFAMOR DANEK, INC.
9010000510
In Commercial Distribution

  • 00643169408524 ()


  • Orthopaedic implant driver

N/A - 00643169373372

DRIVER 5107463 OLIF51 PIN DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5107463
In Commercial Distribution

  • 00643169373372 ()


  • General internal orthopaedic fixation system implantation kit

Navigated Spine Instruments - 10888857488106

Navigated Screw Inserter, Mesa 2
K2M, INC.
6201-N90001-K
In Commercial Distribution

  • 10888857488106 ()
6201-N90001-K

  • Surgical screwdriver, reusable

Navigated Spine Instruments - 10888857488090

Navigated Screw Inserter, Everest MI
K2M, INC.
5101-N90000-K
In Commercial Distribution

  • 10888857488090 ()
5101-N90000-K

  • Surgical screwdriver, reusable

Navigated Spine Instruments - 10888857488083

Navigated Screw Inserter, Everest Locking
K2M, INC.
2901-N90098-K
In Commercial Distribution

  • 10888857488083 ()
2901-N90098-K

  • Surgical screwdriver, reusable

Power Dental USA - D94357730

ORTHODONTIC BENDING DRIVER
Power Dental U.S.A. Inc.
5773
In Commercial Distribution

  • D94357730 ()
5773

  • Orthodontic pliers

EVEREST® Spinal System - 10888857468900

Driver, Height Adjustment, Size 25
K2M, INC.
SP-4143
In Commercial Distribution

  • 10888857468900 ()

  • Size 25 Hexalobe
SP-4143

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Reusable Instruments - 00643169442023

DRIVER EX1213044 MAS SCREW G5
MEDTRONIC SOFAMOR DANEK, INC.
EX1213044
In Commercial Distribution

  • 00643169442023 ()


  • Orthopaedic implant driver

CD HORIZON® Spinal System - 00643169440326

MULTIPLIER 25130500 NGSP TORQUE MULTIPLR
MEDTRONIC SOFAMOR DANEK, INC.
25130500
In Commercial Distribution

  • 00643169440326 ()


  • Surgical screwdriver, reusable

CD HORIZON® Spinal System - 00643169440265

DRIVER NAV1400 NGSP CANN NAV DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
NAV1400
In Commercial Distribution

  • 00643169440265 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

K2M General Instruments - 10888857517516

Driver Shaft
K2M, INC.
PRO-1014
In Commercial Distribution

  • 10888857517516 ()
PRO-1014

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Navigated Spine Instruments - 10888857514799

Navigated Screw Inserter, Everest XT
K2M, INC.
5101-N90161-K
In Commercial Distribution

  • 10888857514799 ()
5101-N90161-K

  • Surgical screwdriver, reusable

Navigated Spine Instruments - 10888857514782

Navigated Screw Inserter, Yukon
K2M, INC.
7601-N90003-K
In Commercial Distribution

  • 10888857514782 ()
7601-N90003-K

  • Surgical screwdriver, reusable

YUKON OCT Spinal System - 10888857494459

Short Tapered Driver, Size 15
K2M, INC.
SP-4235
In Commercial Distribution

  • 10888857494459 ()

  • Size 15 Hexalobe
SP-4235

  • Orthopaedic prosthesis implantation positioning instrument, reusable

OZARK Cervical Plate System - 10888857488649

Screw Driver w/ Thread, Size 10
K2M, INC.
SP-4212
In Commercial Distribution

  • 10888857488649 ()

  • Size 10 Hexalobe
SP-4212

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Reusable Instruments - 00643169433151

DRIVER X0913084 6.35MM PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
X0913084
In Commercial Distribution

  • 00643169433151 ()


  • Orthopaedic implant driver

CHESAPEAKE® Stabilization System - 10888857516984

Universal Driver, Size 20
K2M, INC.
PRO-1020
In Commercial Distribution

  • 10888857516984 ()

  • Size 20 Hexalobe
PRO-1020

  • Orthopaedic prosthesis implantation positioning instrument, reusable

MESA® Spinal System - 10888857516885

Driver, Hex Connection (Short)
K2M, INC.
SP-4259
In Commercial Distribution

  • 10888857516885 ()
SP-4259

  • Orthopaedic prosthesis implantation positioning instrument, reusable

N/A - 00643169428843

DRIVER 4591000 ESSENCE MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
4591000
In Commercial Distribution

  • 00643169428843 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169417434

SCREWDRIVER X0313269
MEDTRONIC SOFAMOR DANEK, INC.
X0313269
In Commercial Distribution

  • 00643169417434 ()


  • Orthopaedic implant driver

NIAGARA® Lateral Access System - 10888857469532

Blade Set Screw Driver, Size 15
K2M, INC.
AC01-90120
In Commercial Distribution

  • 10888857469532 ()
AC01-90120

  • Orthopaedic prosthesis implantation positioning instrument, reusable

YUKON OCT Spinal System - 10888857469235

Nut Driver
K2M, INC.
7601-90188
In Commercial Distribution

  • 10888857469235 ()
7601-90188

  • Orthopaedic prosthesis implantation positioning instrument, reusable

MESA® Spinal System - 10888857466081

Driver, Height Adjustment Size 25
K2M, INC.
SP-4109
In Commercial Distribution

  • 10888857466081 ()

  • Hexalobe Size 25
SP-4109

  • Orthopaedic inorganic implant inserter/extractor, reusable

VERTEX® Reconstruction System - 00643169474895

DRIVER NAV2081 VERT THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV2081
In Commercial Distribution

  • 00643169474895 ()


  • Surgical screwdriver, reusable

CD HORIZON® Spinal System - 00643169468771

DRIVER X1013216 STEP 5.5/6.0 RMAS SOLID
MEDTRONIC SOFAMOR DANEK, INC.
X1013216
In Commercial Distribution

  • 00643169468771 ()

  • 5.5/6.0mm


  • Bone tap, reusable

CD HORIZON® Spinal System - 00643169468740

DRIVER X1013213 STEP 5.5/6.0 MAS CANN
MEDTRONIC SOFAMOR DANEK, INC.
X1013213
In Commercial Distribution

  • 00643169468740 ()

  • 5.5/6.0mm


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

CD HORIZON® Spinal System - 00643169468733

DRIVER X1013212 STEP 5.5/6.0 MAS SOLID
MEDTRONIC SOFAMOR DANEK, INC.
X1013212
In Commercial Distribution

  • 00643169468733 ()

  • 5.5/6.0mm


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

CD HORIZON® Spinal System - 00643169468634

DRIVER X1013202 CANN RETAINING TWIST
MEDTRONIC SOFAMOR DANEK, INC.
X1013202
In Commercial Distribution

  • 00643169468634 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

T2 STRATOSPHERE™ Expandable Corpectomy System - 00643169631359

DRIVER 4360420 20/25MM EXPANSION
MEDTRONIC SOFAMOR DANEK, INC.
4360420
In Commercial Distribution

  • 00643169631359 ()


  • Surgical screwdriver, reusable

T2 STRATOSPHERE™ Expandable Corpectomy System - 00643169631342

DRIVER 4360413 13MM EXPANSION
MEDTRONIC SOFAMOR DANEK, INC.
4360413
In Commercial Distribution

  • 00643169631342 ()


  • Surgical screwdriver, reusable

T2 STRATOSPHERE™ Expandable Corpectomy System - 00643169631335

DRIVER 4369225 20/25MM ANGLED EXPANSION
MEDTRONIC SOFAMOR DANEK, INC.
4369225
In Commercial Distribution

  • 00643169631335 ()


  • Surgical screwdriver, reusable
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