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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 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
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 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 5
Paragon 28, Inc.
P10-942-SZ05
In Commercial Distribution

  • 00889795063380 ()
P10-942-SZ05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Sizing Resection Block, Size 4
Paragon 28, Inc.
P10-942-SZ04
In Commercial Distribution

  • 00889795063373 ()
P10-942-SZ04

  • 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
Tibial Sizing Resection Block, Size 1
Paragon 28, Inc.
P10-942-SZ01
In Commercial Distribution

  • 00889795063342 ()
P10-942-SZ01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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