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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 - 00889795063069

Talar Decoupled Resection, Split Shim, +6mm
Paragon 28, Inc.
P10-942-DT16
In Commercial Distribution

  • 00889795063069 ()
P10-942-DT16

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795063052

Talar Decoupled Resection, Split Shim, +5mm
Paragon 28, Inc.
P10-942-DT15
In Commercial Distribution

  • 00889795063052 ()
P10-942-DT15

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795063045

Talar Decoupled Resection, Split Shim, +4mm
Paragon 28, Inc.
P10-942-DT14
In Commercial Distribution

  • 00889795063045 ()
P10-942-DT14

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795063014

Talar Decoupled Resection, Split Shim, +1mm
Paragon 28, Inc.
P10-942-DT11
In Commercial Distribution

  • 00889795063014 ()
P10-942-DT11

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795063007

Top Hat, Ø3.5mm
Paragon 28, Inc.
P10-942-35TH
In Commercial Distribution

  • 00889795063007 ()
P10-942-35TH

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795062925

Tibial Alignment Distal Body
Paragon 28, Inc.
P10-941-AL03
In Commercial Distribution

  • 00889795062925 ()
P10-941-AL03

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795062918

Tibial Alignment Telescoping Base
Paragon 28, Inc.
P10-941-AL02
In Commercial Distribution

  • 00889795062918 ()
P10-941-AL02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795061836

Phantom TTC Nail, 13.0 X 250mm, RIGHT
Paragon 28, Inc.
P31-330-250R-S
In Commercial Distribution

  • 00889795061836 ()
P31-330-250R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795061812

Phantom TTC Nail, 13.0 X 200mm, RIGHT
Paragon 28, Inc.
P31-330-200R-S
In Commercial Distribution

  • 00889795061812 ()
P31-330-200R-S

  • Arthrodesis intramedullary nail, non-distracting

Special Instrument - 00889795151780

Special Instrument, Straight Nail Short Dual Calc Screw Guide Assembly
Paragon 28, Inc.
SP31-950-0007
In Commercial Distribution

  • 00889795151780 ()
SP31-950-0007

  • Surgical drill guide, reusable
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