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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 - 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 - 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 - 00889795059635

APEX 3D™ Tibia, Arc, Left, Size 2, Long, 3DP
Paragon 28, Inc.
P10-100-BL2L-S
In Commercial Distribution

  • 00889795059635 ()
P10-100-BL2L-S

  • Fixed-bearing total ankle prosthesis

HammerTube™ System - 00889795057723

HammerTube™ System Implant Kit, Ø3.50 x 16mm, 10°, Sterile
Paragon 28, Inc.
P40-002-0350-SK
In Commercial Distribution

  • 00889795057723 ()
P40-002-0350-SK

  • Phalangeal joint arthrodesis implant

HammerTube™ System - 00889795057716

HammerTube™ System Implant Kit, Ø3.50 x 16mm, 0°, Sterile
Paragon 28, Inc.
P40-001-0350-SK
In Commercial Distribution

  • 00889795057716 ()
P40-001-0350-SK

  • Phalangeal joint arthrodesis implant

HammerTube™ System - 00889795057709

HammerTube™ System Implant Kit, Ø2.75 x 14mm, 10°, Sterile
Paragon 28, Inc.
P40-002-0275-SK
In Commercial Distribution

  • 00889795057709 ()
P40-002-0275-SK

  • Phalangeal joint arthrodesis implant

HammerTube™ System - 00889795057693

HammerTube™ System Implant Kit, Ø2.75 x 14mm, 0°, Sterile
Paragon 28, Inc.
P40-001-0275-SK
In Commercial Distribution

  • 00889795057693 ()
P40-001-0275-SK

  • Phalangeal joint arthrodesis implant

HammerTube System - 00889795057679

HammerTube Implant, 3.50mm, 10° Cannulated
Paragon 28, Inc.
P40-002-0350-S
In Commercial Distribution

  • 00889795057679 ()
P40-002-0350-S

  • Phalangeal joint arthrodesis implant

HammerTube System - 00889795057655

HammerTube Implant, 3.50mm, 0° Cannulated
Paragon 28, Inc.
P40-001-0350-S
In Commercial Distribution

  • 00889795057655 ()
P40-001-0350-S

  • Phalangeal joint arthrodesis implant

Baby Gorilla/Gorilla Plating System - 00889795057594

Silverback, Ankle Fusion, Lower Implant Tray
Paragon 28, Inc.
P50-900-1003
In Commercial Distribution

  • 00889795057594 ()
P50-900-1003

  • Device sterilization/disinfection container, reusable
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