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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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Bun-Yo-Matic™ Lapidus Clamp System - 00889795140135

K-wire Tube, 80mm MAX
Paragon 28, Inc.
P31-941-0080
In Commercial Distribution

  • 00889795140135 ()
P31-941-0080

  • Device sterilization/disinfection container, reusable

APEX 3D S Total Ankle Replacement System - 00889795137951

Short Stem Tibia, FLAT, Short Stem (12X12MM Lattice), Right, Size 6, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-181-BR6S-S
In Commercial Distribution

  • 00889795137951 ()
P11-181-BR6S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137920

Short Stem Tibia, FLAT, Short Stem (12X12MM Lattice), Right, Size 5, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-181-BR5S-S
In Commercial Distribution

  • 00889795137920 ()
P11-181-BR5S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137876

Short Stem Tibia, FLAT, Short Stem (12X10.5MM Lattice), Right, Size 3, Long, 3DP - Sterile
Paragon 28, Inc.
P11-181-BR3L-S
In Commercial Distribution

  • 00889795137876 ()
P11-181-BR3L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137845

Short Stem Tibia, FLAT, Short Stem (12X9MM Lattice), Right, Size 2, Long, 3DP - Sterile
Paragon 28, Inc.
P11-181-BR2L-S
In Commercial Distribution

  • 00889795137845 ()
P11-181-BR2L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137814

Short Stem Tibia, FLAT, Short Stem (12X9MM Lattice), Right, Size 1, Long, 3DP - Sterile
Paragon 28, Inc.
P11-181-BR1L-S
In Commercial Distribution

  • 00889795137814 ()
P11-181-BR1L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137791

Short Stem Tibia, FLAT, Short Stem (12X9MM Lattice), Right, Size 1, Short, 3DP - Sterile
Paragon 28, Inc.
P11-181-BR10-S
In Commercial Distribution

  • 00889795137791 ()
P11-181-BR10-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137777

Short Stem Tibia, FLAT, Short Stem (12X12MM Lattice), Left, Size 6, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-181-BL6S-S
In Commercial Distribution

  • 00889795137777 ()
P11-181-BL6S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137746

Short Stem Tibia, FLAT, Short Stem (12X12MM Lattice), Left, Size 5, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-181-BL5S-S
In Commercial Distribution

  • 00889795137746 ()
P11-181-BL5S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137715

Short Stem Tibia, FLAT, Short Stem (12X10.5MM Lattice), Left, Size 4, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-181-BL4S-S
In Commercial Distribution

  • 00889795137715 ()
P11-181-BL4S-S

  • Fixed-bearing total ankle prosthesis
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