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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 5
Paragon 28, Inc.
P10-944-LL15
In Commercial Distribution

  • 00889795063557 ()
P10-944-LL15

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 1
Paragon 28, Inc.
P10-944-LL11
In Commercial Distribution

  • 00889795063519 ()
P10-944-LL11

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 2
Paragon 28, Inc.
P10-944-LL02
In Commercial Distribution

  • 00889795063465 ()
P10-944-LL02

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 1
Paragon 28, Inc.
P10-944-LL01
In Commercial Distribution

  • 00889795063458 ()
P10-944-LL01

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 1 Narrow
Paragon 28, Inc.
P10-944-LL00
In Commercial Distribution

  • 00889795063441 ()
P10-944-LL00

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Chamfer Resection Router, Ø13mm
Paragon 28, Inc.
P10-944-1375
In Commercial Distribution

  • 00889795063427 ()
P10-944-1375

  • Bone-resection orthopaedic reamer, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Chamfer Resection Router, Ø11mm
Paragon 28, Inc.
P10-944-1175
In Commercial Distribution

  • 00889795063410 ()
P10-944-1175

  • Bone-resection orthopaedic reamer, reusable
Tibial Sizing Resection Block, Size 6
Paragon 28, Inc.
P10-942-SZ06
In Commercial Distribution

  • 00889795063397 ()
P10-942-SZ06

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Sizing Resection Block, Size 3
Paragon 28, Inc.
P10-942-SZ03
In Commercial Distribution

  • 00889795063366 ()
P10-942-SZ03

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Sizing Resection Block, Size 2
Paragon 28, Inc.
P10-942-SZ02
In Commercial Distribution

  • 00889795063359 ()
P10-942-SZ02

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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