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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 - 00889795063113

Tibial Flat Cut, Resection Block, Size 2
Paragon 28, Inc.
P10-942-FL02
In Commercial Distribution

  • 00889795063113 ()
P10-942-FL02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795063076

Talar Decoupled Resection, Split Shim, +7mm, Flat
Paragon 28, Inc.
P10-942-DT17
In Commercial Distribution

  • 00889795063076 ()
P10-942-DT17

  • Orthopaedic prosthesis implantation positioning instrument, reusable

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 - 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 - 00889795063021

Talar Decoupled Resection, Split Shim, +2mm
Paragon 28, Inc.
P10-942-DT12
In Commercial Distribution

  • 00889795063021 ()
P10-942-DT12

  • 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 - 00889795062994

APEX 3D-PS Total Ankle Replacement System, Arc Resection Drill, SS, Ø3.5MM
Paragon 28, Inc.
P10-942-3513
In Commercial Distribution

  • 00889795062994 ()
P10-942-3513

  • Fluted surgical drill bit, single-use

APEX 3D Total Ankle Replacement System - 00889795062970

APEX 3D-PS Total Ankle Replacement System, Tibial Alignment, Joint Line Reference Wing
Paragon 28, Inc.
P10-941-AW01
In Commercial Distribution

  • 00889795062970 ()
P10-941-AW01

  • Orthopaedic fixation implant alignment tool

APEX 3D Total Ankle Replacement System - 00889795062963

APEX 3D-PS Total Ankle Replacement System, Tibial Alignment Guide, Joint Line Pointer ("JLP")
Paragon 28, Inc.
P10-941-AL07
In Commercial Distribution

  • 00889795062963 ()
P10-941-AL07

  • Orthopaedic fixation implant alignment tool
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