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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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Tibial Arc/Flat, Resection Block Size 4
Paragon 28, Inc.
P10-942-RS14
In Commercial Distribution

  • 00889795063311 ()
P10-942-RS14

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Arc/Flat, Resection Block Size 3
Paragon 28, Inc.
P10-942-RS13
In Commercial Distribution

  • 00889795063304 ()
P10-942-RS13

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat Cut, Resection Block, Size 6
Paragon 28, Inc.
P10-942-FL06
In Commercial Distribution

  • 00889795063151 ()
P10-942-FL06

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat Cut, Resection Block, Size 4
Paragon 28, Inc.
P10-942-FL04
In Commercial Distribution

  • 00889795063137 ()
P10-942-FL04

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat Cut, Resection Block, Size 1
Paragon 28, Inc.
P10-942-FL01
In Commercial Distribution

  • 00889795063106 ()
P10-942-FL01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Body, Small
Paragon 28, Inc.
P10-942-DTSM
In Commercial Distribution

  • 00889795063090 ()
P10-942-DTSM

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Split Shim, +5mm
Paragon 28, Inc.
P10-942-DT15
In Commercial Distribution

  • 00889795063052 ()
P10-942-DT15

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Split Shim, +3mm, Chamfer
Paragon 28, Inc.
P10-942-DT13
In Commercial Distribution

  • 00889795063038 ()
P10-942-DT13

  • Orthopaedic prosthesis implantation positioning instrument, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 2, Left
Paragon 28, Inc.
P10-920-TLL2
In Commercial Distribution

  • 00889795062307 ()
P10-920-TLL2

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 1, Left
Paragon 28, Inc.
P10-920-TLL1
In Commercial Distribution

  • 00889795062291 ()
P10-920-TLL1

  • Surgical implant template, reusable
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