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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 - 00889795097682

Phantom TC Nail, 13.0 X 200mm
Paragon 28, Inc.
P31-430-2000-S
In Commercial Distribution

  • 00889795097682 ()
P31-430-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097675

Phantom TC Nail, 13.0 X 175mm
Paragon 28, Inc.
P31-430-1750-S
In Commercial Distribution

  • 00889795097675 ()
P31-430-1750-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097668

Phantom TC Nail, 13.0 X 150mm
Paragon 28, Inc.
P31-430-1500-S
In Commercial Distribution

  • 00889795097668 ()
P31-430-1500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097651

Phantom TC Nail, 11.5 X 300mm
Paragon 28, Inc.
P31-415-3000-S
In Commercial Distribution

  • 00889795097651 ()
P31-415-3000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097644

Phantom TC Nail, 11.5 X 250mm
Paragon 28, Inc.
P31-415-2500-S
In Commercial Distribution

  • 00889795097644 ()
P31-415-2500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097637

Phantom TC Nail, 11.5 X 200mm
Paragon 28, Inc.
P31-415-2000-S
In Commercial Distribution

  • 00889795097637 ()
P31-415-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097620

Phantom TC Nail, 11.5 X 150mm
Paragon 28, Inc.
P31-415-1500-S
In Commercial Distribution

  • 00889795097620 ()
P31-415-1500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097613

Phantom TC Nail, 10.0 X 300mm
Paragon 28, Inc.
P31-400-3000-S
In Commercial Distribution

  • 00889795097613 ()
P31-400-3000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097606

Phantom TC Nail, 10.0 X 250mm
Paragon 28, Inc.
P31-400-2500-S
In Commercial Distribution

  • 00889795097606 ()
P31-400-2500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097590

Phantom TC Nail, 10.0 X 200mm
Paragon 28, Inc.
P31-400-2000-S
In Commercial Distribution

  • 00889795097590 ()
P31-400-2000-S

  • Arthrodesis intramedullary nail, non-distracting

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 - 00889795097576

AVITRAC™ Core, MTP Reamer, Ø13 mm, STERILE
Paragon 28, Inc.
P01-901-1301-S
In Commercial Distribution

  • 00889795097576 ()
P01-901-1301-S

  • Bone-resection orthopaedic reamer, single-use

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 - 00889795097545

General Instrument, Lamina Spreader
Paragon 28, Inc.
P99-150-0030
In Commercial Distribution

  • 00889795097545 ()
P99-150-0030

  • Hand-held surgical retractor, reusable

APEX 3D Total Ankle Replacement System - 00889795097538

APEX 3D™ Tibia, Flat, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-101-BR6S-S
In Commercial Distribution

  • 00889795097538 ()
P10-101-BR6S-S

  • Fixed-bearing total ankle prosthesis

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

APEX 3D Total Ankle Replacement System - 00889795097507

APEX 3D™ Tibia, Arc, Left, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-100-BL6S-S
In Commercial Distribution

  • 00889795097507 ()
P10-100-BL6S-S

  • Fixed-bearing total ankle prosthesis

Baby Gorilla®/Gorilla® Plating System - 00889795097491

AVITRAC™ Core, MTP Reamer, Ø13 mm
Paragon 28, Inc.
P01-901-1301
In Commercial Distribution

  • 00889795097491 ()
P01-901-1301

  • Bone-resection orthopaedic reamer, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795097484

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

  • 00889795097484 ()
P01-901-1101

  • Bone-resection orthopaedic reamer, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795097477

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

  • 00889795097477 ()
P01-901-0901

  • Bone-resection orthopaedic reamer, reusable

Monster® Screw System - 00889795097460

Precision® JMF™ Screw Washer Caddy Lid
Paragon 28, Inc.
P25-900-WSCL
In Commercial Distribution

  • 00889795097460 ()
P25-900-WSCL

  • Device sterilization/disinfection container, reusable

Monster® Screw System - 00889795097453

Precision® JMF™ Screw Washer Caddy Base
Paragon 28, Inc.
P25-900-WSCD
In Commercial Distribution

  • 00889795097453 ()
P25-900-WSCD

  • Device sterilization/disinfection container, reusable

Monster® Screw System - 00889795097446

Precision® JMF™ Screw Solid Caddy Base
Paragon 28, Inc.
P25-900-SCBS
In Commercial Distribution

  • 00889795097446 ()
P25-900-SCBS

  • Device sterilization/disinfection container, reusable

Monster® Screw System - 00889795097439

1.6mm S/S Tube - No Cap
Paragon 28, Inc.
P25-900-TBE1
In Commercial Distribution

  • 00889795097439 ()
P25-900-TBE1

  • Device sterilization/disinfection container, reusable

Monster® Screw System - 00889795097422

Precision® JMF™ Screw Cannulated Caddy Base
Paragon 28, Inc.
P25-900-SCBC
In Commercial Distribution

  • 00889795097422 ()
P25-900-SCBC

  • Device sterilization/disinfection container, reusable

HammerTube System - 00889795097415

HammerToe, Caddy, Lid
Paragon 28, Inc.
P40-CAD-LID1
In Commercial Distribution

  • 00889795097415 ()
P40-CAD-LID1

  • Device sterilization/disinfection container, reusable

HammerTube System - 00889795097408

HammerToe, Caddy, Insert
Paragon 28, Inc.
P40-CAD-INS1
In Commercial Distribution

  • 00889795097408 ()
P40-CAD-INS1

  • Device sterilization/disinfection container, reusable

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 - 00889795076397

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 18MM, NEUTRAL
Paragon 28, Inc.
P10-310-I518-S
In Commercial Distribution

  • 00889795076397 ()
P10-310-I518-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 - 00889795076359

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 14MM, NEUTRAL
Paragon 28, Inc.
P10-310-I514-S
In Commercial Distribution

  • 00889795076359 ()
P10-310-I514-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076335

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 12MM, NEUTRAL
Paragon 28, Inc.
P10-310-I512-S
In Commercial Distribution

  • 00889795076335 ()
P10-310-I512-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076328

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 11MM, NEUTRAL
Paragon 28, Inc.
P10-310-I511-S
In Commercial Distribution

  • 00889795076328 ()
P10-310-I511-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

APEX 3D Total Ankle Replacement System - 00889795076304

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 9MM, NEUTRAL
Paragon 28, Inc.
P10-310-I509-S
In Commercial Distribution

  • 00889795076304 ()
P10-310-I509-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076298

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 8MM, NEUTRAL
Paragon 28, Inc.
P10-310-I508-S
In Commercial Distribution

  • 00889795076298 ()
P10-310-I508-S

  • Fixed-bearing total ankle prosthesis
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