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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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Power Dental USA - D94357730

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

  • D94357730 ()
5773

  • Orthodontic pliers

Power Dental USA - D9434223MT00

MALLET MEAD MINI, PLASTIC REPLACEMENT TIP, SET OF 2
Power Dental U.S.A. Inc.
4223MT
In Commercial Distribution

  • D9434223MT00 ()
4223MT

  • Surgical mallet

CHESAPEAKE Stabilization System - 10888857560062

Universal Driver Size 20
K2M, INC.
PRO-1313-02
In Commercial Distribution

  • 10888857560062 ()
PRO-1313-02

  • 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

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 - 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 - 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 - 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 - 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 - 10888857551633

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

  • 10888857551633 ()
8030-90203

  • Bone nail driver

MESA Spinal System - 10888857551169

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

  • 10888857551169 ()
PRO-1209

  • Surgical screwdriver, reusable

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

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

NIAGARA® Lateral Access System - 10888857436077

Straight Driver, Size 25
K2M, INC.
AC01-90098
In Commercial Distribution

  • 10888857436077 ()
AC01-90098

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASCADIA Interbody System - 10888857431461

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

  • 10888857431461 ()
7902-90106

  • Orthopaedic prosthesis implantation positioning instrument, reusable

EVEREST Spinal System - 10888857431386

K-Wire Driver
K2M, INC.
SP-3209
In Commercial Distribution

  • 10888857431386 ()
SP-3209

  • Orthopaedic prosthesis implantation positioning instrument, reusable

RAVINE™ Access System - 10888857427365

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

  • 10888857427365 ()
2701-90235

  • Bone nail driver

EVEREST Spinal System - 10888857423541

Final Shear Driver
K2M, INC.
2901-90239
In Commercial Distribution

  • 10888857423541 ()
2901-90239

  • Orthopaedic prosthesis implantation positioning instrument, reusable

EVEREST Spinal System - 10888857422766

Torque Limiting Shaft Compression/Distraction
K2M, INC.
5101-90265
In Commercial Distribution

  • 10888857422766 ()
5101-90265

  • Surgical screwdriver, reusable

EVEREST Spinal System - 10888857421660

Provisional Shear Set Screw driver (Long)
K2M, INC.
2901-90238
In Commercial Distribution

  • 10888857421660 ()
2901-90238

  • Orthopaedic prosthesis implantation positioning instrument, reusable

EVEREST Spinal System - 10888857421653

Provisional Shear Set Screw driver (Short)
K2M, INC.
2901-90237
In Commercial Distribution

  • 10888857421653 ()
2901-90237

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CAYMAN® Plate System - 10888857421431

Tapered Driver, Size 20
K2M, INC.
4508-90164
In Commercial Distribution

  • 10888857421431 ()

  • Size 20 Hexalobe
4508-90164

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Premium Starter Kit, TSV - D990ZVTSPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
ZVTS-PSK
In Commercial Distribution

  • D990ZVTSPSK0 ()


  • Dental prosthesis/implant abutment screw analog, single-use
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Steel dental bur, reusable
  • Surgical screwdriver, reusable

Retrieval Tool 1PK, ZimVie - D990ZVRT0

No Description
SMART DENTURE CONVERSIONS, LLC
ZV-RT
In Commercial Distribution

  • D990ZVRT0 ()


  • Surgical screwdriver, reusable

Low Torque Driver 1PK, ZimVie - D990ZVLTD0

No Description
SMART DENTURE CONVERSIONS, LLC
ZV-LTD
In Commercial Distribution

  • D990ZVLTD0 ()


  • Surgical screwdriver, reusable

Premium Starter Kit, Low Profile - D990ZVLPPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
ZVLP-PSK
In Commercial Distribution

  • D990ZVLPPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental prosthesis/implant abutment screw
  • Dental implant abutment analog, laboratory
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental prosthesis/implant abutment screw analog, single-use

Starter Kit, Straumann - D990SKST0

No Description
SMART DENTURE CONVERSIONS, LLC
SK-ST
In Commercial Distribution

  • D990SKST0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Starter Kit, Unigrip - D990SK0

No Description
SMART DENTURE CONVERSIONS, LLC
SK
In Commercial Distribution

  • D990SK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Starter Kit, SDC BioHorizons - D990SDBHSK0

No Description
SMART DENTURE CONVERSIONS, LLC
SDBH-SK
In Commercial Distribution

  • D990SDBHSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Premium Starter Kit, SDC BioHorizons - D990SDBHPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
SDBH-PSK
In Commercial Distribution

  • D990SDBHPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Retrieval Tool 1PK - D990RT0

No Description
SMART DENTURE CONVERSIONS, LLC
RT
In Commercial Distribution

  • D990RT0 ()


  • Surgical screwdriver, reusable

Premium Starter Kit, Straumann - D990PSKST0

No Description
SMART DENTURE CONVERSIONS, LLC
PSK-ST
In Commercial Distribution

  • D990PSKST0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Premium Starter Kit, Unigrip - D990PSK0

No Description
SMART DENTURE CONVERSIONS, LLC
PSK
In Commercial Distribution

  • D990PSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental implant analog
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Leixir Starter Kit, Unigrip - D990LXDGSK0

No Description
SMART DENTURE CONVERSIONS, LLC
LXDG-SK
In Commercial Distribution

  • D990LXDGSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Leixir Premium Starter Kit, Unigrip - D990LXDGPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
LXDG-PSK
In Commercial Distribution

  • D990LXDGPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Torque Driver 1PK - D990LTD0

No Description
SMART DENTURE CONVERSIONS, LLC
LTD
In Commercial Distribution

  • D990LTD0 ()


  • Surgical screwdriver, reusable
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