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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 Hindfoot TTC/TC Nail System - 00889795140500

Explant Hook 2.0
Paragon 28, Inc.
P31-958-0006
In Commercial Distribution

  • 00889795140500 ()
P31-958-0006

  • Orthopaedic inorganic implant inserter/extractor, single-use

APEX 3D S Total Ankle Replacement System - 00889795140494

Short Stem Tibia, Instrument, Forked Paddle, Flat
Paragon 28, Inc.
P11-851-P041
In Commercial Distribution

  • 00889795140494 ()
P11-851-P041

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D S Total Ankle Replacement System - 00889795140487

Short Stem Tibia, Instrument, Flat Paddle - 2
Paragon 28, Inc.
P11-851-P032
In Commercial Distribution

  • 00889795140487 ()
P11-851-P032

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D S Total Ankle Replacement System - 00889795140463

Short Stem Tibia, Instrument, Implantation Paddle
Paragon 28, Inc.
P11-851-P021
In Commercial Distribution

  • 00889795140463 ()
P11-851-P021

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D S Total Ankle Replacement System - 00889795140449

Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 6 - FLAT
Paragon 28, Inc.
P11-810-TUF6
In Commercial Distribution

  • 00889795140449 ()
P11-810-TUF6

  • Surgical drill guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140425

Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 4 - FLAT
Paragon 28, Inc.
P11-810-TUF4
In Commercial Distribution

  • 00889795140425 ()
P11-810-TUF4

  • Surgical drill guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140401

Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 2 - FLAT
Paragon 28, Inc.
P11-810-TUF2
In Commercial Distribution

  • 00889795140401 ()
P11-810-TUF2

  • Surgical drill guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140388

Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 6 - ARC
Paragon 28, Inc.
P11-810-TUA6
In Commercial Distribution

  • 00889795140388 ()
P11-810-TUA6

  • Surgical drill guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795137890

Short Stem Tibia, FLAT, Short Stem (12X10.5MM Lattice), Right, Size 4, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-181-BR4S-S
In Commercial Distribution

  • 00889795137890 ()
P11-181-BR4S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137845

Short Stem Tibia, FLAT, Short Stem (12X9MM Lattice), Right, Size 2, Long, 3DP - Sterile
Paragon 28, Inc.
P11-181-BR2L-S
In Commercial Distribution

  • 00889795137845 ()
P11-181-BR2L-S

  • Fixed-bearing total ankle prosthesis
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