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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, 4-Bar Distractor, Tibia Paddle, Constrained
Paragon 28, Inc.
P10-951-P001
In Commercial Distribution

  • 00889795063717 ()
P10-951-P001

  • Orthopaedic surgical distractor, internal
APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor
Paragon 28, Inc.
P10-951-4BAR
In Commercial Distribution

  • 00889795063700 ()
P10-951-4BAR

  • Orthopaedic surgical distractor, internal
Talar Recut Guide 2mm Dorsal Cut
Paragon 28, Inc.
P10-944-TCR1
In Commercial Distribution

  • 00889795063687 ()
P10-944-TCR1

  • Osteotomy guide, reusable
APEX 3D-PS Total Ankle Replacement System, Chamfer Checker, AP Double-Ended, SS
Paragon 28, Inc.
P10-944-TCC2
In Commercial Distribution

  • 00889795063670 ()
P10-944-TCC2

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 4 & 5
Paragon 28, Inc.
P10-944-PSI3
In Commercial Distribution

  • 00889795063649 ()
P10-944-PSI3

  • Osteotomy guide, reusable
APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 1 Narrow & 1
Paragon 28, Inc.
P10-944-PSI1
In Commercial Distribution

  • 00889795063625 ()
P10-944-PSI1

  • Osteotomy guide, reusable
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 5
Paragon 28, Inc.
P10-944-LL25
In Commercial Distribution

  • 00889795063618 ()
P10-944-LL25

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 2
Paragon 28, Inc.
P10-944-LL22
In Commercial Distribution

  • 00889795063588 ()
P10-944-LL22

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 1
Paragon 28, Inc.
P10-944-LL21
In Commercial Distribution

  • 00889795063571 ()
P10-944-LL21

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 1 Narrow
Paragon 28, Inc.
P10-944-LL20
In Commercial Distribution

  • 00889795063564 ()
P10-944-LL20

  • Orthopaedic reamer guide
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