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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 - 00889795137012

3.9mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-3931
In Commercial Distribution

  • 00889795137012 ()
P36-915-3931

  • Bone-resection orthopaedic reamer, single-use

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

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 - 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 - 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

Phantom Hindfoot TTC/TC Nail System - 00889795061775

Phantom TTC Nail, 13.0 X 150mm, RIGHT
Paragon 28, Inc.
P31-330-150R-S
In Commercial Distribution

  • 00889795061775 ()
P31-330-150R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795061744

Phantom TTC Nail, 11.5 X 300mm, LEFT
Paragon 28, Inc.
P31-315-300L-S
In Commercial Distribution

  • 00889795061744 ()
P31-315-300L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795061713

Phantom TTC Nail, 11.5 X 200mm, RIGHT
Paragon 28, Inc.
P31-315-200R-S
In Commercial Distribution

  • 00889795061713 ()
P31-315-200R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795061690

Phantom TTC Nail, 11.5 X 150mm, RIGHT
Paragon 28, Inc.
P31-315-150R-S
In Commercial Distribution

  • 00889795061690 ()
P31-315-150R-S

  • Arthrodesis intramedullary nail, non-distracting
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