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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, Anterior Chamfer Resection Insert, Single-Slotted, Size 4
Paragon 28, Inc.
P10-944-LL14
In Commercial Distribution

  • 00889795063540 ()
P10-944-LL14

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 3
Paragon 28, Inc.
P10-944-LL13
In Commercial Distribution

  • 00889795063533 ()
P10-944-LL13

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 2
Paragon 28, Inc.
P10-944-LL12
In Commercial Distribution

  • 00889795063526 ()
P10-944-LL12

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 1 Narrow
Paragon 28, Inc.
P10-944-LL10
In Commercial Distribution

  • 00889795063502 ()
P10-944-LL10

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 5
Paragon 28, Inc.
P10-944-LL05
In Commercial Distribution

  • 00889795063496 ()
P10-944-LL05

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 4
Paragon 28, Inc.
P10-944-LL04
In Commercial Distribution

  • 00889795063489 ()
P10-944-LL04

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 3
Paragon 28, Inc.
P10-944-LL03
In Commercial Distribution

  • 00889795063472 ()
P10-944-LL03

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Peg Router
Paragon 28, Inc.
P10-944-4013
In Commercial Distribution

  • 00889795063434 ()
P10-944-4013

  • Bone-resection orthopaedic reamer, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Chamfer Resection Router, Ø9mm
Paragon 28, Inc.
P10-944-0975
In Commercial Distribution

  • 00889795063403 ()
P10-944-0975

  • Bone-resection orthopaedic reamer, reusable
Tibial Sizing Resection Block, Size 5
Paragon 28, Inc.
P10-942-SZ05
In Commercial Distribution

  • 00889795063380 ()
P10-942-SZ05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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