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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 - 00889795060068

APEX 3D™ Tibia, Flat, Right, Size 5, Standard, 3DP
Paragon 28, Inc.
P10-101-BR5S-S
In Commercial Distribution

  • 00889795060068 ()
P10-101-BR5S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795060051

APEX 3D™ Tibia, Flat, Right, Size 5, Long, 3DP
Paragon 28, Inc.
P10-101-BR5L-S
In Commercial Distribution

  • 00889795060051 ()
P10-101-BR5L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795060044

APEX 3D™ Tibia, Flat, Right, Size 4, Standard, 3DP
Paragon 28, Inc.
P10-101-BR4S-S
In Commercial Distribution

  • 00889795060044 ()
P10-101-BR4S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795060037

APEX 3D™ Tibia, Flat, Right, Size 4, Long, 3DP
Paragon 28, Inc.
P10-101-BR4L-S
In Commercial Distribution

  • 00889795060037 ()
P10-101-BR4L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795060020

APEX 3D™ Tibia, Flat, Right, Size 3, Standard, 3DP
Paragon 28, Inc.
P10-101-BR3S-S
In Commercial Distribution

  • 00889795060020 ()
P10-101-BR3S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795060013

APEX 3D™ Tibia, Flat, Right, Size 3, Long, 3DP
Paragon 28, Inc.
P10-101-BR3L-S
In Commercial Distribution

  • 00889795060013 ()
P10-101-BR3L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795060006

APEX 3D™ Tibia, Flat, Right, Size 2, Standard, 3DP
Paragon 28, Inc.
P10-101-BR2S-S
In Commercial Distribution

  • 00889795060006 ()
P10-101-BR2S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059994

APEX 3D™ Tibia, Flat, Right, Size 2, Long, 3DP
Paragon 28, Inc.
P10-101-BR2L-S
In Commercial Distribution

  • 00889795059994 ()
P10-101-BR2L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059987

APEX 3D™ Tibia, Flat, Right, Size 1, Standard, 3DP
Paragon 28, Inc.
P10-101-BR1S-S
In Commercial Distribution

  • 00889795059987 ()
P10-101-BR1S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059970

APEX 3D™ Tibia, Flat, Right, Size 1, Long, 3DP
Paragon 28, Inc.
P10-101-BR1L-S
In Commercial Distribution

  • 00889795059970 ()
P10-101-BR1L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059963

APEX 3D™ Tibia, Flat, Right, Size 1, Short, 3DP
Paragon 28, Inc.
P10-101-BR10-S
In Commercial Distribution

  • 00889795059963 ()
P10-101-BR10-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059956

APEX 3D™ Tibia, Flat, Left, Size 6, Long, 3DP
Paragon 28, Inc.
P10-101-BL6L-S
In Commercial Distribution

  • 00889795059956 ()
P10-101-BL6L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059949

APEX 3D™ Tibia, Flat, Left, Size 5, Standard, 3DP
Paragon 28, Inc.
P10-101-BL5S-S
In Commercial Distribution

  • 00889795059949 ()
P10-101-BL5S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059932

APEX 3D™ Tibia, Flat, Left, Size 5, Long, 3DP
Paragon 28, Inc.
P10-101-BL5L-S
In Commercial Distribution

  • 00889795059932 ()
P10-101-BL5L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059925

APEX 3D™ Tibia, Flat, Left, Size 4, Standard, 3DP
Paragon 28, Inc.
P10-101-BL4S-S
In Commercial Distribution

  • 00889795059925 ()
P10-101-BL4S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059918

APEX 3D™ Tibia, Flat, Left, Size 4, Long, 3DP
Paragon 28, Inc.
P10-101-BL4L-S
In Commercial Distribution

  • 00889795059918 ()
P10-101-BL4L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059901

APEX 3D™ Tibia, Flat, Left, Size 3, Standard, 3DP
Paragon 28, Inc.
P10-101-BL3S-S
In Commercial Distribution

  • 00889795059901 ()
P10-101-BL3S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059895

APEX 3D™ Tibia, Flat, Left, Size 3, Long, 3DP
Paragon 28, Inc.
P10-101-BL3L-S
In Commercial Distribution

  • 00889795059895 ()
P10-101-BL3L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059888

APEX 3D™ Tibia, Flat, Left, Size 2, Standard, 3DP
Paragon 28, Inc.
P10-101-BL2S-S
In Commercial Distribution

  • 00889795059888 ()
P10-101-BL2S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059871

APEX 3D™ Tibia, Flat, Left, Size 2, Long, 3DP
Paragon 28, Inc.
P10-101-BL2L-S
In Commercial Distribution

  • 00889795059871 ()
P10-101-BL2L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059864

APEX 3D™ Tibia, Flat, Left, Size 1, Standard, 3DP
Paragon 28, Inc.
P10-101-BL1S-S
In Commercial Distribution

  • 00889795059864 ()
P10-101-BL1S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059857

APEX 3D™ Tibia, Flat, Left, Size 1, Long, 3DP
Paragon 28, Inc.
P10-101-BL1L-S
In Commercial Distribution

  • 00889795059857 ()
P10-101-BL1L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059840

APEX 3D™ Tibia, Flat, Left, Size 1, Short, 3DP
Paragon 28, Inc.
P10-101-BL10-S
In Commercial Distribution

  • 00889795059840 ()
P10-101-BL10-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059833

APEX 3D™ Tibia, Arc, Right, Size 6, Long, 3DP
Paragon 28, Inc.
P10-100-BR6L-S
In Commercial Distribution

  • 00889795059833 ()
P10-100-BR6L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059826

APEX 3D™ Tibia, Arc, Right, Size 5, Standard, 3DP
Paragon 28, Inc.
P10-100-BR5S-S
In Commercial Distribution

  • 00889795059826 ()
P10-100-BR5S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059819

APEX 3D™ Tibia, Arc, Right, Size 5, Long, 3DP
Paragon 28, Inc.
P10-100-BR5L-S
In Commercial Distribution

  • 00889795059819 ()
P10-100-BR5L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059802

APEX 3D™ Tibia, Arc, Right, Size 4, Standard, 3DP
Paragon 28, Inc.
P10-100-BR4S-S
In Commercial Distribution

  • 00889795059802 ()
P10-100-BR4S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059796

APEX 3D™ Tibia, Arc, Right, Size 4, Long, 3DP
Paragon 28, Inc.
P10-100-BR4L-S
In Commercial Distribution

  • 00889795059796 ()
P10-100-BR4L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059789

APEX 3D™ Tibia, Arc, Right, Size 3, Standard, 3DP
Paragon 28, Inc.
P10-100-BR3S-S
In Commercial Distribution

  • 00889795059789 ()
P10-100-BR3S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059772

APEX 3D™ Tibia, Arc, Right, Size 3, Long, 3DP
Paragon 28, Inc.
P10-100-BR3L-S
In Commercial Distribution

  • 00889795059772 ()
P10-100-BR3L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059765

APEX 3D™ Tibia, Arc, Right, Size 2, Standard, 3DP
Paragon 28, Inc.
P10-100-BR2S-S
In Commercial Distribution

  • 00889795059765 ()
P10-100-BR2S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059758

APEX 3D™ Tibia, Arc, Right, Size 2, Long, 3DP
Paragon 28, Inc.
P10-100-BR2L-S
In Commercial Distribution

  • 00889795059758 ()
P10-100-BR2L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059741

APEX 3D™ Tibia, Arc, Right, Size 1, Standard, 3DP
Paragon 28, Inc.
P10-100-BR1S-S
In Commercial Distribution

  • 00889795059741 ()
P10-100-BR1S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059734

APEX 3D™ Tibia, Arc, Right, Size 1, Long, 3DP
Paragon 28, Inc.
P10-100-BR1L-S
In Commercial Distribution

  • 00889795059734 ()
P10-100-BR1L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795059666

APEX 3D™ Tibia, Arc, Left, Size 3, Standard, 3DP
Paragon 28, Inc.
P10-100-BL3S-S
In Commercial Distribution

  • 00889795059666 ()
P10-100-BL3S-S

  • Fixed-bearing total ankle prosthesis

HammerTube System - 00889795057662

HammerTube Implant, 2.75mm, 10° Cannulated
Paragon 28, Inc.
P40-002-0275-S
In Commercial Distribution

  • 00889795057662 ()
P40-002-0275-S

  • Phalangeal joint arthrodesis implant

HammerTube System - 00889795057648

HammerTube Implant, 2.75mm, 0° Cannulated
Paragon 28, Inc.
P40-001-0275-S
In Commercial Distribution

  • 00889795057648 ()
P40-001-0275-S

  • Phalangeal joint arthrodesis implant

Tenodesis Screw System - 00889795057587

Grappler Interference Screw, Caddy Lid
Paragon 28, Inc.
P41-900-LID
In Commercial Distribution

  • 00889795057587 ()
P41-900-LID

  • Device sterilization/disinfection container, reusable

Grappler Interference Screw System - 00889795057563

Suture Passer w/ Braided Nitinol Loop, Grappler™
Paragon 28, Inc.
P41-960-0020
In Commercial Distribution

  • 00889795057563 ()
P41-960-0020

  • Suturing unit, single-use

Tenodesis Screw System - 00889795057549

Screw Driver Attachment 7.0/8.0mm, Solid , A/O, Trilobe, Grappler
Paragon 28, Inc.
P41-940-7080
In Commercial Distribution

  • 00889795057549 ()
P41-940-7080

  • Surgical screwdriver, reusable
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