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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, Tibia Impaction Protector, Size 2
Paragon 28, Inc.
P10-951-TP02
In Commercial Distribution

  • 00889795063892 ()
P10-951-TP02

  • Orthopaedic implant impactor, reusable
APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Viper Tip, Size 4, SS
Paragon 28, Inc.
P10-951-TBV4
In Commercial Distribution

  • 00889795063854 ()
P10-951-TBV4

  • Orthopaedic surgical distractor, internal
APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Viper Tip, Size 2, SS
Paragon 28, Inc.
P10-951-TBV2
In Commercial Distribution

  • 00889795063830 ()
P10-951-TBV2

  • Orthopaedic surgical distractor, internal
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Coin, Right
Paragon 28, Inc.
P10-951-TBR2
In Commercial Distribution

  • 00889795063816 ()
P10-951-TBR2

  • Orthopaedic implant impactor, reusable
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-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
Talar Recut Guide Posterior Cut
Paragon 28, Inc.
P10-944-TCR2
In Commercial Distribution

  • 00889795063694 ()
P10-944-TCR2

  • Osteotomy guide, reusable
APEX 3D-PS Total Ankle Replacement System, Chamfer Checker, All-in-one, SS
Paragon 28, Inc.
P10-944-TCC1
In Commercial Distribution

  • 00889795063663 ()
P10-944-TCC1

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Square Tip Ronguer
Paragon 28, Inc.
P10-944-STR0
In Commercial Distribution

  • 00889795063656 ()
P10-944-STR0

  • Orthopaedic joint/limb rongeur
APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 2 & 3
Paragon 28, Inc.
P10-944-PSI2
In Commercial Distribution

  • 00889795063632 ()
P10-944-PSI2

  • Osteotomy guide, reusable
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