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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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DynaBridge - 00840124513419

Calc Slide Inserter 12mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI12
In Commercial Distribution

  • 00840124513419 ()
CD-DB-CI12

  • Orthopaedic bone staple driver

DynaBridge - 00840124513402

Calc Slide Inserter 10mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI10
In Commercial Distribution

  • 00840124513402 ()
CD-DB-CI10

  • Orthopaedic bone staple driver

DynaBridge - 00840124513396

Calc Slide Inserter 8mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI08
In Commercial Distribution

  • 00840124513396 ()
CD-DB-CI08

  • Orthopaedic bone staple driver

DynaBridge - 00840124513389

Calc Slide Inserter 6mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI06
In Commercial Distribution

  • 00840124513389 ()
CD-DB-CI06

  • Orthopaedic bone staple driver

DynaBridge - 00840124513372

Calc Slide Inserter 4mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI04
In Commercial Distribution

  • 00840124513372 ()
CD-DB-CI04

  • Orthopaedic bone staple driver

FuzeFix Large - 00840124512795

Driver Torx FT 7.0mm
FUSION ORTHOPEDICS, LLC
CD-FT-3070
In Commercial Distribution

  • 00840124512795 ()
CD-FT-3070

  • Surgical screwdriver, single-use

FuzeFix Large - 00840124512788

Driver Torx FT 5.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-3055
In Commercial Distribution

  • 00840124512788 ()
CD-FT-3055

  • Surgical screwdriver, single-use

HammerTech - 00840124511835

HT 2X Driver (4.5mm)
FUSION ORTHOPEDICS, LLC
TN-2X-3045
In Commercial Distribution

  • 00840124511835 ()


  • Surgical screwdriver, single-use

HammerTech - 00840124511828

HT 2X Driver (3.4mm)
FUSION ORTHOPEDICS, LLC
TN-2X-3034
In Commercial Distribution

  • 00840124511828 ()


  • Surgical screwdriver, single-use

HammerTech - 00840124511811

HT 2X Driver (2.6mm)
FUSION ORTHOPEDICS, LLC
TN-2X-3026
In Commercial Distribution

  • 00840124511811 ()


  • Surgical screwdriver, single-use

HammerTech - 00840124511804

HT 2X Thread Drill (2.2mm)
FUSION ORTHOPEDICS, LLC
CD-2X-1022
In Commercial Distribution

  • 00840124511804 ()


  • Cannulated surgical drill bit, single-use

HammerTech - 00840124511798

HT 2X Thread Drill (2.0mm)
FUSION ORTHOPEDICS, LLC
CD-2X-1020
In Commercial Distribution

  • 00840124511798 ()


  • Cannulated surgical drill bit, single-use

TopLock - 00840124511514

Drill PEEK Anchor 4.75mm
FUSION ORTHOPEDICS, LLC
CD-TL-1045
In Commercial Distribution

  • 00840124511514 ()
CD-TL-1045

  • Cannulated surgical drill bit, single-use

TopLock - 00840124511507

3.5mm Drill PEEK Anchor
FUSION ORTHOPEDICS, LLC
CD-TL-1035
In Commercial Distribution

  • 00840124511507 ()


  • Cannulated surgical drill bit, single-use

FuzeFix Chamfered Screws - 00840124510340

Chamfered Screw Cannulated Drill 3.0mm (2.1mm)
FUSION ORTHOPEDICS, LLC
CD-CS-1030
In Commercial Distribution

  • 00840124510340 ()


  • Cannulated surgical drill bit, single-use

PolyLock - 00840124510258

MiniLock Solid Driver (3.5mm)
FUSION ORTHOPEDICS, LLC
CD-ML-3025
In Commercial Distribution

  • 00840124510258 ()


  • Surgical screwdriver, single-use

PolyLock - 00840124510210

MiniLock Cannulated Driver (3.5mm)
FUSION ORTHOPEDICS, LLC
CD-ML-3520
In Commercial Distribution

  • 00840124510210 ()


  • Surgical screwdriver, single-use

FuzeFix Chamfered Screws - 00840124509719

Chamfered Screw Cannulated Driver 3.0mm
FUSION ORTHOPEDICS, LLC
CD-CS-3030
In Commercial Distribution

  • 00840124509719 ()
CD-CS-3030

  • Surgical screwdriver, single-use

FuzeFix Chamfered Screws - 00840124509320

Chamfered Screw Calibrated Drill Cannulated 4.0mm (3.2 mm)
FUSION ORTHOPEDICS, LLC
CD-CS-1040
In Commercial Distribution

  • 00840124509320 ()
CD-CS-1040

  • Cannulated surgical drill bit, single-use

FuzeFix Chamfered Screws - 00840124509313

Chamfered Screw Calibrated Drill Cannulated 3.0mm (2.7mm)
FUSION ORTHOPEDICS, LLC
CD-CS-1035
In Commercial Distribution

  • 00840124509313 ()
CD-CS-1035

  • Cannulated surgical drill bit, single-use

FuzeFix Chamfered Screws - 00840124509306

Cannulated Driver, CS 4.0mm
FUSION ORTHOPEDICS, LLC
CD-CS-3040
In Commercial Distribution

  • 00840124509306 ()
CD-CS-3040

  • Surgical screwdriver, single-use

FuzeFix Chamfered Screws - 00840124509290

Cannulated Driver, CS 3.5mm
FUSION ORTHOPEDICS, LLC
CD-CS-3035
In Commercial Distribution

  • 00840124509290 ()
CD-CS-3035

  • Surgical screwdriver, single-use

HammerTech - 00840124508163

HT Ti Calibrated Drill Angled Large
FUSION ORTHOPEDICS, LLC
CD-01-6133
In Commercial Distribution

  • 00840124508163 ()
CD-01-6133

  • Cannulated surgical drill bit, single-use

HammerTech - 00840124508156

HT Ti Calibrated Drill Angled Medium
FUSION ORTHOPEDICS, LLC
CD-01-6129
In Commercial Distribution

  • 00840124508156 ()
CD-01-6129

  • Cannulated surgical drill bit, single-use

HammerTech - 00840124508149

HT Ti Calibrated Drill Angled Small
FUSION ORTHOPEDICS, LLC
CD-01-6127
In Commercial Distribution

  • 00840124508149 ()
CD-01-6127

  • Cannulated surgical drill bit, single-use

HammerTech - 00840124508132

HT Ti Calibrated Drill Angled Extra Small
FUSION ORTHOPEDICS, LLC
CD-01-6124
In Commercial Distribution

  • 00840124508132 ()
CD-01-6124

  • Cannulated surgical drill bit, single-use

HammerTech - 00840124508125

HT Ti Calibrated Drill Angled Petite
FUSION ORTHOPEDICS, LLC
CD-01-6120
In Commercial Distribution

  • 00840124508125 ()
CD-01-6120

  • Cannulated surgical drill bit, single-use

LapiLock - 00840124507029

MP Olive Wire Non-Threaded
FUSION ORTHOPEDICS, LLC
CD-LL-0991
In Commercial Distribution

  • 00840124507029 ()


  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124507012

MP Olive Wire Threaded
FUSION ORTHOPEDICS, LLC
CD-LL-0990
In Commercial Distribution

  • 00840124507012 ()


  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124506381

Short Driver 3.0 mm
FUSION ORTHOPEDICS, LLC
CD-LL-3030
In Commercial Distribution

  • 00840124506381 ()
CD-LL-3030

  • Surgical screwdriver, reusable

LapiLock - 00840124506374

Olive Wire Short Thread
FUSION ORTHOPEDICS, LLC
CD-LL-0030
In Commercial Distribution

  • 00840124506374 ()
CD-LL-0030

  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124506367

Olive Wire Non-Threaded
FUSION ORTHOPEDICS, LLC
CD-LL-0045
In Commercial Distribution

  • 00840124506367 ()
CD-LL-0045

  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124506350

Spacer 5.0 mm
FUSION ORTHOPEDICS, LLC
TN-LL-6505
Not in Commercial Distribution

  • 00840124506350 ()
TN-LL-6505

  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124506343

Spacer Lock
FUSION ORTHOPEDICS, LLC
TN-LL-6900
Not in Commercial Distribution

  • 00840124506343 ()
TN-LL-6900

  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124506336

Spacer Lock Long
FUSION ORTHOPEDICS, LLC
TN-LL-6901
Not in Commercial Distribution

  • 00840124506336 ()
TN-LL-6901

  • Cannulated surgical drill bit, single-use, non-sterile

PolyLock - 00840124506282

Bunion Plate Distall Drill 2.7mm SB
FUSION ORTHOPEDICS, LLC
CD-SB-1921
In Commercial Distribution

  • 00840124506282 ()
CD-SB-1921

  • Cannulated surgical drill bit, single-use, non-sterile

PolyLock - 00840124506275

Bunion Plate Distal Drill 2.4mm
FUSION ORTHOPEDICS, LLC
CD-SB-1918
In Commercial Distribution

  • 00840124506275 ()
CD-SB-1918

  • Cannulated surgical drill bit, single-use, non-sterile

PolyLock - 00840124506268

Bunion Plate Lag Drill SB
FUSION ORTHOPEDICS, LLC
CD-SB-1919
In Commercial Distribution

  • 00840124506268 ()
CD-SB-1919

  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124506091

Folcrum 4.0 mm
FUSION ORTHOPEDICS, LLC
TN-LL-6504
In Commercial Distribution

  • 00840124506091 ()
TN-LL-6504

  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124506084

Spacer 3.0mm
FUSION ORTHOPEDICS, LLC
TN-LL-6503
Not in Commercial Distribution

  • 00840124506084 ()
TN-LL-6503

  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124506077

Spacer 2.0mm
FUSION ORTHOPEDICS, LLC
TN-LL-6502
Not in Commercial Distribution

  • 00840124506077 ()
TN-LL-6502

  • Cannulated surgical drill bit, single-use, non-sterile

LapiLock - 00840124506039

Olive Wire Threaded
FUSION ORTHOPEDICS, LLC
CD-LL-0040
In Commercial Distribution

  • 00840124506039 ()
CD-LL-0040

  • Cannulated surgical drill bit, single-use, non-sterile

PASS TULIP PRIME - 03613720293644

DRIVER A22020200 NUT DRIVER
MEDICREA INTERNATIONAL
A22020200
In Commercial Distribution

  • 03613720293644 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

CUSTOM - 03613720274674

OFFSET NUT DRIVER FOR PASS LP
MEDICREA INTERNATIONAL
A99180700
Not in Commercial Distribution

  • 03613720274674 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Invictus - 00190376419145

Final Driver, Long
ALPHATEC SPINE, INC.
17908
In Commercial Distribution

  • 00190376419145 ()


  • Surgical screwdriver, reusable

Invictus - 00190376419121

Final Driver, Stop
ALPHATEC SPINE, INC.
17830
In Commercial Distribution

  • 00190376419121 ()


  • Surgical screwdriver, reusable

Invictus - 00190376399904

Reduction T27 Screwdriver, Locking
ALPHATEC SPINE, INC.
16811
In Commercial Distribution

  • 00190376399904 ()


  • Surgical screwdriver, reusable

Invictus - 00190376399881

T27 Screwdriver, Locking, Short
ALPHATEC SPINE, INC.
16810-S
In Commercial Distribution

  • 00190376399881 ()


  • Surgical screwdriver, reusable

Invictus - 00190376399874

T27 Screwdriver, Locking, Long
ALPHATEC SPINE, INC.
16810-L
In Commercial Distribution

  • 00190376399874 ()


  • Surgical screwdriver, reusable

Invictus - 00190376399867

T27 Screwdriver, Locking
ALPHATEC SPINE, INC.
16810
In Commercial Distribution

  • 00190376399867 ()


  • Surgical screwdriver, reusable
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