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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-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 3, Right
Paragon 28, Inc.
P10-910-TB3R
In Commercial Distribution

  • 00889795062079 ()
P10-910-TB3R

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 3, Left
Paragon 28, Inc.
P10-910-TB3L
In Commercial Distribution

  • 00889795062062 ()
P10-910-TB3L

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 2, Right
Paragon 28, Inc.
P10-910-TB2R
In Commercial Distribution

  • 00889795062055 ()
P10-910-TB2R

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 2, Left
Paragon 28, Inc.
P10-910-TB2L
In Commercial Distribution

  • 00889795062048 ()
P10-910-TB2L

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 1, Right
Paragon 28, Inc.
P10-910-TB1R
In Commercial Distribution

  • 00889795062031 ()
P10-910-TB1R

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 1, Left
Paragon 28, Inc.
P10-910-TB1L
In Commercial Distribution

  • 00889795062024 ()
P10-910-TB1L

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, 3.0 Pin, 316LVM, Fluted, 160mm
Paragon 28, Inc.
P10-902-3016
In Commercial Distribution

  • 00889795062017 ()
P10-902-3016

  • Orthopaedic bone wire
APEX 3D-PS Total Ankle Replacement System, 3.0 Pin, 316LVM, Fluted, 100mm
Paragon 28, Inc.
P10-902-3010
In Commercial Distribution

  • 00889795062000 ()
P10-902-3010

  • Orthopaedic bone wire
APEX 3D-PS Total Ankle Replacement System, 2.4 Shoulder-Thread Pin, 50mm Thread length
Paragon 28, Inc.
P10-902-2450
In Commercial Distribution

  • 00889795061997 ()
P10-902-2450

  • Orthopaedic bone wire
APEX 3D-PS Total Ankle Replacement System, 2.4 Shoulder-Thread Pin, 25mm Thread length
Paragon 28, Inc.
P10-902-2425
In Commercial Distribution

  • 00889795061980 ()
P10-902-2425

  • Orthopaedic bone wire
APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 6
Paragon 28, Inc.
P10-901-RSP6
In Commercial Distribution

  • 00889795061973 ()
P10-901-RSP6

  • Bone file/rasp, manual, reusable
APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 5
Paragon 28, Inc.
P10-901-RSP5
In Commercial Distribution

  • 00889795061966 ()
P10-901-RSP5

  • Bone file/rasp, manual, reusable
APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 4
Paragon 28, Inc.
P10-901-RSP4
In Commercial Distribution

  • 00889795061959 ()
P10-901-RSP4

  • Bone file/rasp, manual, reusable
APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 3
Paragon 28, Inc.
P10-901-RSP3
In Commercial Distribution

  • 00889795061942 ()
P10-901-RSP3

  • Bone file/rasp, manual, reusable
APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 2
Paragon 28, Inc.
P10-901-RSP2
In Commercial Distribution

  • 00889795061935 ()
P10-901-RSP2

  • Bone file/rasp, manual, reusable
APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 1
Paragon 28, Inc.
P10-901-RSP1
In Commercial Distribution

  • 00889795061928 ()
P10-901-RSP1

  • Bone file/rasp, manual, reusable
APEX 3D-PS Total Ankle Replacement System, Resection Gap Checker, FLAT/Flat-Cut
Paragon 28, Inc.
P10-901-RGF2
In Commercial Distribution

  • 00889795061911 ()
P10-901-RGF2

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Resection Gap Checker, FLAT/Chamfer-Cut
Paragon 28, Inc.
P10-901-RGF1
In Commercial Distribution

  • 00889795061904 ()
P10-901-RGF1

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Resection Gap Checker, ARC/Flat-Cut
Paragon 28, Inc.
P10-901-RGA2
In Commercial Distribution

  • 00889795061898 ()
P10-901-RGA2

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Resection Gap Checker, ARC/Chamfer-Cut
Paragon 28, Inc.
P10-901-RGA1
In Commercial Distribution

  • 00889795061881 ()
P10-901-RGA1

  • Surgical implant template, reusable
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