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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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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 - 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 - 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

APEX 3D S Total Ankle Replacement System - 00889795136817

Short Stem Tibia, Instrument, Drill Bit Cap D9, Short
Paragon 28, Inc.
P11-854-C09S
In Commercial Distribution

  • 00889795136817 ()
P11-854-C09S

  • Cannulated surgical drill bit, single-use

APEX 3D Total Ankle Replacement System - 00889795136800

3.5 Hex Driver, Ball Nose, Short
Paragon 28, Inc.
P99-150-HB35-SHORT
In Commercial Distribution

  • 00889795136800 ()
P99-150-HB35-SHORT

  • Surgical screwdriver, reusable

APEX 3D Total Ankle Replacement System - 00889795136794

3.5 Hex Driver, Ball Nose, Standard
Paragon 28, Inc.
P99-150-HB35
In Commercial Distribution

  • 00889795136794 ()
P99-150-HB35

  • Surgical screwdriver, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795136558

Phantom Hindfoot Nail, Compression End Cap, Long
Paragon 28, Inc.
P31-111-0000-07
In Commercial Distribution

  • 00889795136558 ()
P31-111-0000-07

  • Bone nail end-cap

Phantom Hindfoot TTC/TC Nail System - 00889795136541

Phantom Hindfoot Nail, Compression End Cap, Short
Paragon 28, Inc.
P31-111-0000-03
In Commercial Distribution

  • 00889795136541 ()
P31-111-0000-03

  • Bone nail end-cap
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