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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™ Cross-linked Vitamin E POLY, SIZE 2 x 16MM, NEUTRAL
Paragon 28, Inc.
P10-310-I216-S
In Commercial Distribution

  • 00889795072320 ()
P10-310-I216-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 10MM, NEUTRAL
Paragon 28, Inc.
P10-310-I210-S
In Commercial Distribution

  • 00889795072269 ()
P10-310-I210-S

  • Fixed-bearing total ankle prosthesis
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, Poly Trial Insert, Size 5, 11mm
Paragon 28, Inc.
P10-930-I511
In Commercial Distribution

  • 00889795062864 ()
P10-930-I511

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 4, 10mm
Paragon 28, Inc.
P10-930-I410
In Commercial Distribution

  • 00889795062789 ()
P10-930-I410

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 4, 6mm
Paragon 28, Inc.
P10-930-I406
In Commercial Distribution

  • 00889795062741 ()
P10-930-I406

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 3, 9mm
Paragon 28, Inc.
P10-930-I309
In Commercial Distribution

  • 00889795062703 ()
P10-930-I309

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 1, 8mm
Paragon 28, Inc.
P10-930-I108
In Commercial Distribution

  • 00889795062550 ()
P10-930-I108

  • Surgical implant template, reusable
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