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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 - 00889795118042

Ghost 2.0 Proximal Extension
Paragon 28, Inc.
P31-950-2035
In Commercial Distribution

  • 00889795118042 ()
P31-950-2035

  • Orthopaedic fixation implant alignment tool

Phantom Hindfoot TTC/TC Nail System - 00889795118035

Ghost 2.0 Targeting Device
Paragon 28, Inc.
P31-950-2000
In Commercial Distribution

  • 00889795118035 ()
P31-950-2000

  • Orthopaedic fixation implant alignment tool

Monkey Rings™ External Fixation System - 00889795118004

Anti Microbial pads
Paragon 28, Inc.
P45-600-1000-S
In Commercial Distribution

  • 00889795118004 ()
P45-600-1000-S

  • Absorbent underpad, antimicrobial

Monkey Rings™ External Fixation System - 00889795117991

Ø6.0mm Half Pin Quick Connect (SP1306)
Paragon 28, Inc.
P45-965-6000-S
In Commercial Distribution

  • 00889795117991 ()
P45-965-6000-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795117984

Ø5.0mm Half Pin Quick Connect (SP1305)
Paragon 28, Inc.
P45-965-5000-S
In Commercial Distribution

  • 00889795117984 ()
P45-965-5000-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795117977

Ø4.0mm Half Pin Quick Connect (SF1304)
Paragon 28, Inc.
P45-965-4000-S
In Commercial Distribution

  • 00889795117977 ()
P45-965-4000-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795117960

Ø3.2mm x 195mm Drill for HA Half Pins (SF1324)
Paragon 28, Inc.
P45-960-3219-S
In Commercial Distribution

  • 00889795117960 ()
P45-960-3219-S

  • Cannulated surgical drill bit, single-use

Monkey Rings™ External Fixation System - 00889795117953

Half Pin, Self Drilling, Ø6.0mm X 50mm, 180mm SHANK LENGTH, HA COATED (ST156180HA)
Paragon 28, Inc.
P45-199-6045-S
In Commercial Distribution

  • 00889795117953 ()
P45-199-6045-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795117946

Half Pin, Self Drilling, Ø5.0mm X 50mm, 180mm SHANK LENGTH, HA COATED (ST145180HA)
Paragon 28, Inc.
P45-199-5045-S
In Commercial Distribution

  • 00889795117946 ()
P45-199-5045-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795117939

Half Pin, Self Drilling, Ø4.0mm x 34mm, 120mm SHANK LENGTH, HA COATED (ST134120HA)
Paragon 28, Inc.
P45-199-4035-S
In Commercial Distribution

  • 00889795117939 ()
P45-199-4035-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795117922

Wire Cutter
Paragon 28, Inc.
P99-150-0121
In Commercial Distribution

  • 00889795117922 ()
P99-150-0121

  • Orthopaedic implantable-device cutter

Monkey Rings™ External Fixation System - 00889795117915

Tang Angled Socket Wrench, 10mm
Paragon 28, Inc.
P45-513-0003
In Commercial Distribution

  • 00889795117915 ()
P45-513-0003

  • Surgical torque wrench, reusable

Monkey Rings™ External Fixation System - 00889795117908

Speed Nut
Paragon 28, Inc.
P45-941-0002
In Commercial Distribution

  • 00889795117908 ()
P45-941-0002

  • External orthopaedic fixation system, single-use

APEX 3D Total Ankle Replacement System - 00889795117892

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 10MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I510-S
In Commercial Distribution

  • 00889795117892 ()
P10-31P-I510-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117885

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 9MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I509-S
In Commercial Distribution

  • 00889795117885 ()
P10-31P-I509-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117878

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 8MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I508-S
In Commercial Distribution

  • 00889795117878 ()
P10-31P-I508-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117861

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 7MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I507-S
In Commercial Distribution

  • 00889795117861 ()
P10-31P-I507-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117854

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 6MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I506-S
In Commercial Distribution

  • 00889795117854 ()
P10-31P-I506-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117847

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 10MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I410-S
In Commercial Distribution

  • 00889795117847 ()
P10-31P-I410-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117830

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 9MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I409-S
In Commercial Distribution

  • 00889795117830 ()
P10-31P-I409-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117823

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 8MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I408-S
In Commercial Distribution

  • 00889795117823 ()
P10-31P-I408-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117816

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 7MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I407-S
In Commercial Distribution

  • 00889795117816 ()
P10-31P-I407-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117809

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 6MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I406-S
In Commercial Distribution

  • 00889795117809 ()
P10-31P-I406-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117793

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 10MM, 3.5MM POST OFFSET
Paragon 28, Inc.
P10-31P-I310-S
In Commercial Distribution

  • 00889795117793 ()
P10-31P-I310-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117786

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 9MM, 3.5MM POST OFFSET
Paragon 28, Inc.
P10-31P-I309-S
In Commercial Distribution

  • 00889795117786 ()
P10-31P-I309-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117779

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 8MM, 3.5MM POST OFFSET
Paragon 28, Inc.
P10-31P-I308-S
In Commercial Distribution

  • 00889795117779 ()
P10-31P-I308-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117762

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 7MM, 3.5MM POST OFFSET
Paragon 28, Inc.
P10-31P-I307-S
In Commercial Distribution

  • 00889795117762 ()
P10-31P-I307-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117755

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 6MM, 3.5MM POST OFFSET
Paragon 28, Inc.
P10-31P-I306-S
In Commercial Distribution

  • 00889795117755 ()
P10-31P-I306-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117748

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 10MM, 3.25MM POST OFFSET
Paragon 28, Inc.
P10-31P-I210-S
In Commercial Distribution

  • 00889795117748 ()
P10-31P-I210-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117731

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 9MM, 3.25MM POST OFFSET
Paragon 28, Inc.
P10-31P-I209-S
In Commercial Distribution

  • 00889795117731 ()
P10-31P-I209-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117724

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 8MM, 3.25MM POST OFFSET
Paragon 28, Inc.
P10-31P-I208-S
In Commercial Distribution

  • 00889795117724 ()
P10-31P-I208-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117717

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 7MM, 3.25MM POST OFFSET
Paragon 28, Inc.
P10-31P-I207-S
In Commercial Distribution

  • 00889795117717 ()
P10-31P-I207-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117700

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 6MM, 3.25MM POST OFFSET
Paragon 28, Inc.
P10-31P-I206-S
In Commercial Distribution

  • 00889795117700 ()
P10-31P-I206-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117694

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 10MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I110-S
In Commercial Distribution

  • 00889795117694 ()
P10-31P-I110-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117687

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 9MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I109-S
In Commercial Distribution

  • 00889795117687 ()
P10-31P-I109-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117670

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 8MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I108-S
In Commercial Distribution

  • 00889795117670 ()
P10-31P-I108-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117663

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 7MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I107-S
In Commercial Distribution

  • 00889795117663 ()
P10-31P-I107-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117656

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 6MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I106-S
In Commercial Distribution

  • 00889795117656 ()
P10-31P-I106-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117649

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 10MM, 4MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I510-S
In Commercial Distribution

  • 00889795117649 ()
P10-31A-I510-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117632

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 9MM, 4MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I509-S
In Commercial Distribution

  • 00889795117632 ()
P10-31A-I509-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117625

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 8MM, 4MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I508-S
In Commercial Distribution

  • 00889795117625 ()
P10-31A-I508-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117618

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 7MM, 4MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I507-S
In Commercial Distribution

  • 00889795117618 ()
P10-31A-I507-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117601

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 6MM, 4MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I506-S
In Commercial Distribution

  • 00889795117601 ()
P10-31A-I506-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117595

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 10MM, 3.75MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I410-S
In Commercial Distribution

  • 00889795117595 ()
P10-31A-I410-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117588

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 9MM, 3.75MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I409-S
In Commercial Distribution

  • 00889795117588 ()
P10-31A-I409-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117571

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 8MM, 3.75MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I408-S
In Commercial Distribution

  • 00889795117571 ()
P10-31A-I408-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117564

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 7MM, 3.75MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I407-S
In Commercial Distribution

  • 00889795117564 ()
P10-31A-I407-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117557

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 6MM, 3.75MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I406-S
In Commercial Distribution

  • 00889795117557 ()
P10-31A-I406-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117540

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 10MM, 3.5MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I310-S
In Commercial Distribution

  • 00889795117540 ()
P10-31A-I310-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117533

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 9MM, 3.5MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I309-S
In Commercial Distribution

  • 00889795117533 ()
P10-31A-I309-S

  • Fixed-bearing total ankle prosthesis
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