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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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SAHARA™ Stabilization System - 10888857461345

Retaining Driver, Size 20
K2M, INC.
7902-90118
In Commercial Distribution

  • 10888857461345 ()

  • Size 20
7902-90118

  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAHARA™ Stabilization System - 10888857457966

Expansion Driver
K2M, INC.
7902-90061
In Commercial Distribution

  • 10888857457966 ()
7902-90061

  • Orthopaedic prosthesis implantation positioning instrument, reusable

K2M General Instruments - 10888857558441

Locking Screw Inserter
K2M, INC.
PRO-1286
In Commercial Distribution

  • 10888857558441 ()
PRO-1286

  • Surgical screwdriver, reusable

CAYMAN Plate System - 10888857557451

Capture Driver Size 25
K2M, INC.
PRO-1239
In Commercial Distribution

  • 10888857557451 ()
PRO-1239

  • Surgical screwdriver, reusable

DENALI Spinal System - 10888857555662

Set Screw Removal Wrench
K2M, INC.
PRO-1260
In Commercial Distribution

  • 10888857555662 ()
PRO-1260

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552388

ES2 Q Screwdriver
K2M, INC.
48113200
In Commercial Distribution

  • 10888857552388 ()
48113200

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552364

ES2 Q Screwdriver Sleeve
K2M, INC.
48113202
In Commercial Distribution

  • 10888857552364 ()
48113202

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552340

Xia 3/Serrato Q Screwdriver Sleeve
K2M, INC.
48113302
In Commercial Distribution

  • 10888857552340 ()
48113302

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552326

Everest Q Drive Shaft
K2M, INC.
48113401
In Commercial Distribution

  • 10888857552326 ()
48113401

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552302

Everest Q Screwdriver Sleeve
K2M, INC.
48113403
In Commercial Distribution

  • 10888857552302 ()
48113403

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552272

Everest MI XT Q Screwdriver Sleeve
K2M, INC.
48113407
In Commercial Distribution

  • 10888857552272 ()
48113407

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552258

Mesa 2 Q Screwdriver
K2M, INC.
48113500
In Commercial Distribution

  • 10888857552258 ()
48113500

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552241

Mesa 2 Q Screwdriver Drive Shaft
K2M, INC.
48113501
In Commercial Distribution

  • 10888857552241 ()
48113501

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857552067

Monoaxial Screwdriver Shaft
K2M, INC.
PRO-1232-04
In Commercial Distribution

  • 10888857552067 ()
PRO-1232-04

  • Surgical screwdriver, reusable

NAPA Access System - 10888857551633

Fixation Pin Driver
K2M, INC.
8030-90203
In Commercial Distribution

  • 10888857551633 ()
8030-90203

  • Bone nail driver

K2M General Instruments - 10888857551107

Polyaxial Screw Inserter
K2M, INC.
PRO-1191
In Commercial Distribution

  • 10888857551107 ()
PRO-1191

  • Orthopaedic implant driver

YUKON OCT Spinal System - 10888857550896

Locking Screw Inserter
K2M, INC.
PRO-1135
In Commercial Distribution

  • 10888857550896 ()
PRO-1135

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857527713

Driver
K2M, INC.
PRO-1091-02
In Commercial Distribution

  • 10888857527713 ()
PRO-1091-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

K2M General Instruments - 10888857554313

Screwdriver, Split Tip
K2M, INC.
PRO-1244
In Commercial Distribution

  • 10888857554313 ()
PRO-1244

  • Orthopaedic implant driver

EVEREST Spinal System - 10888857553811

Tapered Driver, Hex Size 30
K2M, INC.
PRO-1223
In Commercial Distribution

  • 10888857553811 ()
PRO-1223

  • Surgical screwdriver, reusable

DENALI Deformity Spinal System - 10888857553460

Screw Inserter (Short)
K2M, INC.
PRO-1235
In Commercial Distribution

  • 10888857553460 ()
PRO-1235

  • Orthopaedic implant driver

Q Pedicle Instruments - 10888857553224

Q Screwdriver Spin Sleeve
K2M, INC.
48140020
In Commercial Distribution

  • 10888857553224 ()
48140020

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857553217

Q Screwdriver Guide Tube
K2M, INC.
48110000
In Commercial Distribution

  • 10888857553217 ()
48110000

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857553200

Q Driver and Probes Instruments Tray
K2M, INC.
48110001
In Commercial Distribution

  • 10888857553200 ()
48110001

  • Instrument tray, reusable

Q Pedicle Instruments - 10888857552371

Xia 3/Serrato/ES2 Q Drive Shaft
K2M, INC.
48113201
In Commercial Distribution

  • 10888857552371 ()
48113201

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552357

Xia 3/Serrato Q Screwdriver
K2M, INC.
48113301
In Commercial Distribution

  • 10888857552357 ()
48113301

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552333

Everest Q Screwdriver
K2M, INC.
48113400
In Commercial Distribution

  • 10888857552333 ()
48113400

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552319

Q Ratchet Screwdriver Quick-Connect
K2M, INC.
48113402
In Commercial Distribution

  • 10888857552319 ()
48113402

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552296

Everest MI XT Q Screwdriver
K2M, INC.
48113405
In Commercial Distribution

  • 10888857552296 ()
48113405

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552289

Everest MI XT Q Drive Shaft
K2M, INC.
48113406
In Commercial Distribution

  • 10888857552289 ()
48113406

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552265

Q MIS Screwdriver Guide Tube
K2M, INC.
48113408
In Commercial Distribution

  • 10888857552265 ()
48113408

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552234

Q Threaded Screwdriver Quick-Connect
K2M, INC.
48113502
In Commercial Distribution

  • 10888857552234 ()
48113502

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857552050

Reduction Polyaxial Screwdriver
K2M, INC.
PRO-1232-03
In Commercial Distribution

  • 10888857552050 ()
PRO-1232-03

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857552043

Polyaxial Screwdriver Shaft
K2M, INC.
PRO-1232-02
In Commercial Distribution

  • 10888857552043 ()
PRO-1232-02

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857551848

Locking Screw Inserter
K2M, INC.
PRO-1227
In Commercial Distribution

  • 10888857551848 ()
PRO-1227

  • Surgical screwdriver, reusable

Oasys® - 10888857551824

Inserter
K2M, INC.
PRO-1222
In Commercial Distribution

  • 10888857551824 ()
PRO-1222

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857551749

Retaining Screwdriver
K2M, INC.
PRO-1204
In Commercial Distribution

  • 10888857551749 ()
PRO-1204

  • Surgical screwdriver, reusable

NAPA Access System - 10888857551640

Driver Size 25
K2M, INC.
8030-90204
In Commercial Distribution

  • 10888857551640 ()
8030-90204

  • Orthopaedic prosthesis implantation positioning instrument, reusable

YUKON OCT Spinal System - 10888857551404

Tapered Set Screw Inserter, Double Ended Size 15
K2M, INC.
PRO-1193
In Commercial Distribution

  • 10888857551404 ()
PRO-1193

  • Surgical screwdriver, reusable

MESA Spinal System - 10888857551169

Screwdriver Size 25
K2M, INC.
PRO-1209
In Commercial Distribution

  • 10888857551169 ()
PRO-1209

  • Surgical screwdriver, reusable

CHESAPEAKE® Stabilization System - 10888857550537

Universal Tapered Driver Size 20
K2M, INC.
PRO-1187-05
In Commercial Distribution

  • 10888857550537 ()
PRO-1187-05

  • Orthopaedic implant driver

K2M General Instruments - 10888857550308

Locking Screw Inserter
K2M, INC.
PRO-1186-04
In Commercial Distribution

  • 10888857550308 ()
PRO-1186-04

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857550292

Locking Screw Inserter, Short
K2M, INC.
PRO-1186-03
In Commercial Distribution

  • 10888857550292 ()
PRO-1186-03

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857550285

Locking Screw Inserter
K2M, INC.
PRO-1186-02
In Commercial Distribution

  • 10888857550285 ()
PRO-1186-02

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857550278

Locking Screw Inserter, Short
K2M, INC.
PRO-1186-01
In Commercial Distribution

  • 10888857550278 ()
PRO-1186-01

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857549869

Polyaxial Screwdriver, Locking
K2M, INC.
PRO-1154
In Commercial Distribution

  • 10888857549869 ()
PRO-1154

  • Surgical screwdriver, reusable

OZARK Cervical Plate System - 10888857548602

Screw Driver w/ Thread
K2M, INC.
PRO-1156
In Commercial Distribution

  • 10888857548602 ()
PRO-1156

  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAHARA™ Stabilization System - 10888857443037

Driver, Size 10
K2M, INC.
7902-90104
In Commercial Distribution

  • 10888857443037 ()

  • Size 10
7902-90104

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NIAGARA® Lateral Access System - 10888857436084

Extended Driver Size 15
K2M, INC.
AC01-90065
In Commercial Distribution

  • 10888857436084 ()
AC01-90065

  • Orthopaedic implant driver

CASCADIA Interbody System - 10888857431461

Tapered Driver Size 20
K2M, INC.
7902-90106
In Commercial Distribution

  • 10888857431461 ()
7902-90106

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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