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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 Total Ankle Replacement System - 00889795142900

Tibia, Flat, Left, Size 1, Long, 3DP
Paragon 28, Inc.
P10-101-BL1L-S
In Commercial Distribution

  • 00889795142900 ()
P10-101-BL1L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142894

Tibia, Flat, Left, Size 1, Short, 3DP
Paragon 28, Inc.
P10-101-BL10-S
In Commercial Distribution

  • 00889795142894 ()
P10-101-BL10-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142887

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

  • 00889795142887 ()
P10-100-BR6S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142870

Tibia, Arc, Right, Size 6, Long, 3DP
Paragon 28, Inc.
P10-100-BR6L-S
In Commercial Distribution

  • 00889795142870 ()
P10-100-BR6L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142863

Tibia, Arc, Right, Size 5, Standard, 3DP
Paragon 28, Inc.
P10-100-BR5S-S
In Commercial Distribution

  • 00889795142863 ()
P10-100-BR5S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142856

Tibia, Arc, Right, Size 5, Long, 3DP
Paragon 28, Inc.
P10-100-BR5L-S
In Commercial Distribution

  • 00889795142856 ()
P10-100-BR5L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142825

Tibia, Arc, Right, Size 3, Standard, 3DP
Paragon 28, Inc.
P10-100-BR3S-S
In Commercial Distribution

  • 00889795142825 ()
P10-100-BR3S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142818

Tibia, Arc, Right, Size 3, Long, 3DP
Paragon 28, Inc.
P10-100-BR3L-S
In Commercial Distribution

  • 00889795142818 ()
P10-100-BR3L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142795

Tibia, Arc, Right, Size 2, Long, 3DP
Paragon 28, Inc.
P10-100-BR2L-S
In Commercial Distribution

  • 00889795142795 ()
P10-100-BR2L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142788

Tibia, Arc, Right, Size 1, Standard, 3DP
Paragon 28, Inc.
P10-100-BR1S-S
In Commercial Distribution

  • 00889795142788 ()
P10-100-BR1S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142771

Tibia, Arc, Right, Size 1, Long, 3DP
Paragon 28, Inc.
P10-100-BR1L-S
In Commercial Distribution

  • 00889795142771 ()
P10-100-BR1L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142757

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

  • 00889795142757 ()
P10-100-BL6S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142740

Tibia, Arc, Left, Size 6, Long, 3DP
Paragon 28, Inc.
P10-100-BL6L-S
In Commercial Distribution

  • 00889795142740 ()
P10-100-BL6L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142726

Tibia, Arc, Left, Size 5, Long, 3DP
Paragon 28, Inc.
P10-100-BL5L-S
In Commercial Distribution

  • 00889795142726 ()
P10-100-BL5L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142702

Tibia, Arc, Left, Size 4, Long, 3DP
Paragon 28, Inc.
P10-100-BL4L-S
In Commercial Distribution

  • 00889795142702 ()
P10-100-BL4L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142696

Tibia, Arc, Left, Size 3, Standard, 3DP
Paragon 28, Inc.
P10-100-BL3S-S
In Commercial Distribution

  • 00889795142696 ()
P10-100-BL3S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142658

Tibia, Arc, Left, Size 1, Standard, 3DP
Paragon 28, Inc.
P10-100-BL1S-S
In Commercial Distribution

  • 00889795142658 ()
P10-100-BL1S-S

  • Fixed-bearing total ankle prosthesis

MAVEN™ Patient-Specific Instrumentation - 00889795142504

MAVEN PSI TAR, APEX 3D S AP Tibia Spacer, Right
Paragon 28, Inc.
P11-PSI-R105
In Commercial Distribution

  • 00889795142504 ()
P11-PSI-R105

  • Surgical implant template, single-use

Specialty Instrument, Hardware Removal Caddy - 00889795141590

Hardware Removal Caddy, Lid
Paragon 28, Inc.
SP99-LID-0001
In Commercial Distribution

  • 00889795141590 ()
SP99-LID-0001

  • Device sterilization/disinfection container, reusable

Specialty Instrument, Hardware Removal Caddy - 00889795141583

Hardware Removal Caddy, Base
Paragon 28, Inc.
SP99-CAD-0001
In Commercial Distribution

  • 00889795141583 ()
SP99-CAD-0001

  • Device sterilization/disinfection container, reusable

Monkey Bars™ Pin to Bar External Fixation System - 00889795141576

175mm X 210mm Aluminum Kickstand
Paragon 28, Inc.
P85-510-175U
In Commercial Distribution

  • 00889795141576 ()
P85-510-175U

  • External orthopaedic fixation system, single-use

APEX 3D S Total Ankle Replacement System - 00889795140586

Short Stem Tibia, Instrument, Drill Bit, Tall, D12 x H14
Paragon 28, Inc.
P11-854-D12T
In Commercial Distribution

  • 00889795140586 ()
P11-854-D12T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795140579

Short Stem Tibia, Instrument, Drill Bit, Pilot, D12 x H7.5
Paragon 28, Inc.
P11-854-D12S
In Commercial Distribution

  • 00889795140579 ()
P11-854-D12S

  • Cannulated surgical drill bit, single-use

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 - 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 - 00889795140456

Short Stem Tibia, Instrument, Forked Paddle, Arc
Paragon 28, Inc.
P11-851-P051
In Commercial Distribution

  • 00889795140456 ()
P11-851-P051

  • 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 - 00889795140432

Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 5 - FLAT
Paragon 28, Inc.
P11-810-TUF5
In Commercial Distribution

  • 00889795140432 ()
P11-810-TUF5

  • 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 - 00889795140418

Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 3 - FLAT
Paragon 28, Inc.
P11-810-TUF3
In Commercial Distribution

  • 00889795140418 ()
P11-810-TUF3

  • 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 - 00889795140395

Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 1 - FLAT
Paragon 28, Inc.
P11-810-TUF1
In Commercial Distribution

  • 00889795140395 ()
P11-810-TUF1

  • 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 - 00889795140371

Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 5 - ARC
Paragon 28, Inc.
P11-810-TUA5
In Commercial Distribution

  • 00889795140371 ()
P11-810-TUA5

  • Surgical drill guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140364

Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 4 - ARC
Paragon 28, Inc.
P11-810-TUA4
In Commercial Distribution

  • 00889795140364 ()
P11-810-TUA4

  • Surgical drill guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140357

Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 3 - ARC
Paragon 28, Inc.
P11-810-TUA3
In Commercial Distribution

  • 00889795140357 ()
P11-810-TUA3

  • Surgical drill guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140340

Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 2 - ARC
Paragon 28, Inc.
P11-810-TUA2
In Commercial Distribution

  • 00889795140340 ()
P11-810-TUA2

  • Surgical drill guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140333

Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 1 - ARC
Paragon 28, Inc.
P11-810-TUA1
In Commercial Distribution

  • 00889795140333 ()
P11-810-TUA1

  • Surgical drill guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140326

Short Stem Tibia, Instrument, Trial Holder
Paragon 28, Inc.
P11-810-TH01
In Commercial Distribution

  • 00889795140326 ()
P11-810-TH01

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

APEX 3D S Total Ankle Replacement System - 00889795140319

Short Stem Tibia, Instrument, Tibial Docking Fixture, Sizes 5-6
Paragon 28, Inc.
P11-810-TB56
In Commercial Distribution

  • 00889795140319 ()
P11-810-TB56

  • Fixed-bearing total ankle prosthesis
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