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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 Total Ankle Replacement System - 00889795063786

APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Dimple, Left
Paragon 28, Inc.
P10-951-TBL1
In Commercial Distribution

  • 00889795063786 ()
P10-951-TBL1

  • Orthopaedic implant impactor, reusable

APEX 3D Total Ankle Replacement System - 00889795063779

APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Handle
Paragon 28, Inc.
P10-951-TB00
In Commercial Distribution

  • 00889795063779 ()
P10-951-TB00

  • Surgical instrument handle, non-torque-limiting

APEX 3D Total Ankle Replacement System - 00889795063762

APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Tibia Implantation Paddle
Paragon 28, Inc.
P10-951-P021
In Commercial Distribution

  • 00889795063762 ()
P10-951-P021

  • Orthopaedic surgical distractor, internal

APEX 3D Total Ankle Replacement System - 00889795063755

APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Talus Paddle, Size 4 & 5
Paragon 28, Inc.
P10-951-P013
In Commercial Distribution

  • 00889795063755 ()
P10-951-P013

  • Orthopaedic surgical distractor, internal

APEX 3D Total Ankle Replacement System - 00889795063748

APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Talus Paddle, Size 2 & 3
Paragon 28, Inc.
P10-951-P012
In Commercial Distribution

  • 00889795063748 ()
P10-951-P012

  • Orthopaedic surgical distractor, internal

APEX 3D Total Ankle Replacement System - 00889795063731

APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Talus Paddle, Size 1 Narrow & 1
Paragon 28, Inc.
P10-951-P011
In Commercial Distribution

  • 00889795063731 ()
P10-951-P011

  • Orthopaedic surgical distractor, internal

APEX 3D Total Ankle Replacement System - 00889795063724

APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Tibia Paddle, A-P Translation
Paragon 28, Inc.
P10-951-P002
In Commercial Distribution

  • 00889795063724 ()
P10-951-P002

  • Orthopaedic surgical distractor, internal

APEX 3D Total Ankle Replacement System - 00889795063717

APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Tibia Paddle, Constrained
Paragon 28, Inc.
P10-951-P001
In Commercial Distribution

  • 00889795063717 ()
P10-951-P001

  • Orthopaedic surgical distractor, internal

APEX 3D Total Ankle Replacement System - 00889795063700

APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor
Paragon 28, Inc.
P10-951-4BAR
In Commercial Distribution

  • 00889795063700 ()
P10-951-4BAR

  • Orthopaedic surgical distractor, internal

APEX 3D Total Ankle Replacement System - 00889795063694

Talar Recut Guide Posterior Cut
Paragon 28, Inc.
P10-944-TCR2
In Commercial Distribution

  • 00889795063694 ()
P10-944-TCR2

  • Osteotomy guide, reusable
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