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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 - 00889795061928

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 Total Ankle Replacement System - 00889795061911

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 Total Ankle Replacement System - 00889795061904

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 Total Ankle Replacement System - 00889795061898

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 Total Ankle Replacement System - 00889795061881

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 Total Ankle Replacement System - 00889795061874

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

APEX 3D Total Ankle Replacement System - 00889795061850

APEX 3D-PS Total Ankle Replacement System, Tibial Osteotome, ARC
Paragon 28, Inc.
P10-901-OS01
In Commercial Distribution

  • 00889795061850 ()
P10-901-OS01

  • Orthopaedic osteotome

APEX 3D Total Ankle Replacement System - 00889795061843

APEX 3D-PS Total Ankle Replacement System, T-Handle
Paragon 28, Inc.
P10-901-24TH
In Commercial Distribution

  • 00889795061843 ()
P10-901-24TH

  • Surgical instrument handle, non-torque-limiting

Monkey Rings™ External Fixation System - 00889795128409

MODULAR BALL JOINT
Paragon 28, Inc.
P45-233-1000
In Commercial Distribution

  • 00889795128409 ()
P45-233-1000

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795124555

Bevel Nut, 10mm
Paragon 28, Inc.
P45-940-1001
In Commercial Distribution

  • 00889795124555 ()
P45-940-1001

  • External orthopaedic fixation system, single-use
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