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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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Phantom® Fibula Nail System - 00889795136992

2.6mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-2632
In Commercial Distribution

  • 00889795136992 ()
P36-915-2632

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795136961

2.0mm x 150mm, Trocar K-Wire
Paragon 28, Inc.
P36-912-2015
In Commercial Distribution

  • 00889795136961 ()
P36-912-2015

  • Orthopaedic guidewire, single-use

Phantom® Fibula Nail System - 00889795136954

1.6mm x 230mm, Entry Guidewire, Trocar
Paragon 28, Inc.
P36-912-1623
In Commercial Distribution

  • 00889795136954 ()
P36-912-1623

  • Orthopaedic guidewire, single-use

APEX 3D S Total Ankle Replacement System - 00889795136930

Short Stem Tibia, Instrument, Tibial Docking Fixture, Sizes 1-2
Paragon 28, Inc.
P11-810-TB12
In Commercial Distribution

  • 00889795136930 ()
P11-810-TB12

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795136923

Short Stem Tibia, Instrument, Drill Bit, Pilot, D9 x H7.5
Paragon 28, Inc.
P11-854-D09S
In Commercial Distribution

  • 00889795136923 ()
P11-854-D09S

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136909

2.4 Threaded Shoulder Pin - Short Shank - 50mm Thread Length
Paragon 28, Inc.
P10-912-2450
In Commercial Distribution

  • 00889795136909 ()
P10-912-2450

  • Orthopaedic guidewire, single-use

APEX 3D S Total Ankle Replacement System - 00889795136893

Short Stem Tibia, Instrument, Drill Bit Cap D12, Tall
Paragon 28, Inc.
P11-854-C12T
In Commercial Distribution

  • 00889795136893 ()
P11-854-C12T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136886

Short Stem Tibia, Instrument, Drill Bit Cap D12, Short
Paragon 28, Inc.
P11-854-C12S
In Commercial Distribution

  • 00889795136886 ()
P11-854-C12S

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136879

Short Stem Tibia, Instrument, Drill Bit Cap D10.5, Tall
Paragon 28, Inc.
P11-854-C10T
In Commercial Distribution

  • 00889795136879 ()
P11-854-C10T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136862

Short Stem Tibia, Instrument, Drill Bit Cap D10.5, Short
Paragon 28, Inc.
P11-854-C10S
In Commercial Distribution

  • 00889795136862 ()
P11-854-C10S

  • Cannulated surgical drill bit, single-use
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