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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, Talar Fin Sweeper
Paragon 28, Inc.
P10-920-TLRM
In Commercial Distribution

  • 00889795062406 ()
P10-920-TLRM

  • Bone-resection orthopaedic reamer, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 4, Right
Paragon 28, Inc.
P10-920-TLR4
In Commercial Distribution

  • 00889795062383 ()
P10-920-TLR4

  • Surgical implant template, 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 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 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
APEX 3D-PS Total Ankle Replacement System, Pin Puller
Paragon 28, Inc.
P10-901-PP24
In Commercial Distribution

  • 00889795061874 ()
P10-901-PP24

  • Orthopaedic inorganic implant inserter/extractor, reusable
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