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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 - 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

APEX 3D Total Ankle Replacement System - 00889795062956

APEX 3D-PS Total Ankle Replacement System, Tibial Alignment, Gutter Tool
Paragon 28, Inc.
P10-941-AL06
In Commercial Distribution

  • 00889795062956 ()
P10-941-AL06

  • Orthopaedic fixation implant alignment tool

APEX 3D Total Ankle Replacement System - 00889795062949

Tibial Alignment FASTRAC(TM)
Paragon 28, Inc.
P10-941-AL05
In Commercial Distribution

  • 00889795062949 ()
P10-941-AL05

  • Orthopaedic fixation implant alignment tool

APEX 3D Total Ankle Replacement System - 00889795062932

APEX 3D-PS Total Ankle Replacement System, Tibial Alignment Guide, Lateral Rod
Paragon 28, Inc.
P10-941-AL04
In Commercial Distribution

  • 00889795062932 ()
P10-941-AL04

  • Orthopaedic fixation implant alignment tool

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

APEX 3D Total Ankle Replacement System - 00889795062901

APEX 3D-PS Total Ankle Replacement System, Tibial Alignment Guide, Telescoping Rod
Paragon 28, Inc.
P10-941-AL01
In Commercial Distribution

  • 00889795062901 ()
P10-941-AL01

  • Orthopaedic fixation implant alignment tool

APEX 3D Total Ankle Replacement System - 00889795062895

Joint-Line, Alignment, Pin Tube
Paragon 28, Inc.
P10-940-JL10
In Commercial Distribution

  • 00889795062895 ()
P10-940-JL10

  • Orthopaedic fixation implant alignment tool
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