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

  • 00889795117915 ()
P45-513-0003

  • Surgical torque wrench, reusable
Speed Nut
Paragon 28, Inc.
P45-941-0002
In Commercial Distribution

  • 00889795117908 ()
P45-941-0002

  • External orthopaedic fixation system, single-use
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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ 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
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 8MM, 3.5MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I308-S
In Commercial Distribution

  • 00889795117526 ()
P10-31A-I308-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 7MM, 3.5MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I307-S
In Commercial Distribution

  • 00889795117519 ()
P10-31A-I307-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 6MM, 3.5MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I306-S
In Commercial Distribution

  • 00889795117502 ()
P10-31A-I306-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 10MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I210-S
In Commercial Distribution

  • 00889795117496 ()
P10-31A-I210-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 9MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I209-S
In Commercial Distribution

  • 00889795117489 ()
P10-31A-I209-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 8MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I208-S
In Commercial Distribution

  • 00889795117472 ()
P10-31A-I208-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 7MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I207-S
In Commercial Distribution

  • 00889795117465 ()
P10-31A-I207-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 6MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I206-S
In Commercial Distribution

  • 00889795117458 ()
P10-31A-I206-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 10MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I110-S
In Commercial Distribution

  • 00889795117441 ()
P10-31A-I110-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 9MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I109-S
In Commercial Distribution

  • 00889795117434 ()
P10-31A-I109-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 8MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I108-S
In Commercial Distribution

  • 00889795117427 ()
P10-31A-I108-S

  • Fixed-bearing total ankle prosthesis
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