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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 - 00889795097583

Phantom TC Nail, 10.0 X 150mm
Paragon 28, Inc.
P31-400-1500-S
In Commercial Distribution

  • 00889795097583 ()
P31-400-1500-S

  • Arthrodesis intramedullary nail, non-distracting

AVTRAC MTP Revision System - 00889795097569

AVITRAC™ Core, MTP Reamer, Ø11 mm, STERILE
Paragon 28, Inc.
P01-901-1101-S
In Commercial Distribution

  • 00889795097569 ()
P01-901-1101-S

  • Bone-resection orthopaedic reamer, single-use

AVTRAC MTP Revision System - 00889795097552

AVITRAC™ Core, MTP Reamer, Ø9 mm, STERILE
Paragon 28, Inc.
P01-901-0901-S
In Commercial Distribution

  • 00889795097552 ()
P01-901-0901-S

  • Bone-resection orthopaedic reamer, single-use

APEX 3D Total Ankle Replacement System - 00889795097521

APEX 3D™ Tibia, Flat, Left, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-101-BL6S-S
In Commercial Distribution

  • 00889795097521 ()
P10-101-BL6S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795097514

APEX 3D™ Tibia, Arc, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-100-BR6S-S
In Commercial Distribution

  • 00889795097514 ()
P10-100-BR6S-S

  • Fixed-bearing total ankle prosthesis

HammerTube System - 00889795097392

HammerToe, Caddy, Base
Paragon 28, Inc.
P40-CAD-BASE
In Commercial Distribution

  • 00889795097392 ()
P40-CAD-BASE

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795097385

Gorilla Half Height Instrument Base, Full DIN
Paragon 28, Inc.
P50-900-0012
In Commercial Distribution

  • 00889795097385 ()
P50-900-0012

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795076410

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 20MM, NEUTRAL
Paragon 28, Inc.
P10-310-I520-S
In Commercial Distribution

  • 00889795076410 ()
P10-310-I520-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076373

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 16MM, NEUTRAL
Paragon 28, Inc.
P10-310-I516-S
In Commercial Distribution

  • 00889795076373 ()
P10-310-I516-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076311

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 10MM, NEUTRAL
Paragon 28, Inc.
P10-310-I510-S
In Commercial Distribution

  • 00889795076311 ()
P10-310-I510-S

  • Fixed-bearing total ankle prosthesis
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