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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 - 00889795062505

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 3, Right
Paragon 28, Inc.
P10-921-TLR3
In Commercial Distribution

  • 00889795062505 ()
P10-921-TLR3

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062482

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 1, Right
Paragon 28, Inc.
P10-921-TLR1
In Commercial Distribution

  • 00889795062482 ()
P10-921-TLR1

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062468

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 5, Left
Paragon 28, Inc.
P10-921-TLL5
In Commercial Distribution

  • 00889795062468 ()
P10-921-TLL5

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062451

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 4, Left
Paragon 28, Inc.
P10-921-TLL4
In Commercial Distribution

  • 00889795062451 ()
P10-921-TLL4

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062437

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 2, Left
Paragon 28, Inc.
P10-921-TLL2
In Commercial Distribution

  • 00889795062437 ()
P10-921-TLL2

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062420

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 1, Left
Paragon 28, Inc.
P10-921-TLL1
In Commercial Distribution

  • 00889795062420 ()
P10-921-TLL1

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062406

APEX 3D-PS Total Ankle Replacement System, Talar Fin Sweeper
Paragon 28, Inc.
P10-920-TLRM
In Commercial Distribution

  • 00889795062406 ()
P10-920-TLRM

  • Bone-resection orthopaedic reamer, reusable

APEX 3D Total Ankle Replacement System - 00889795062383

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 4, Right
Paragon 28, Inc.
P10-920-TLR4
In Commercial Distribution

  • 00889795062383 ()
P10-920-TLR4

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795061980

APEX 3D-PS Total Ankle Replacement System, 2.4 Shoulder-Thread Pin, 25mm Thread length
Paragon 28, Inc.
P10-902-2425
In Commercial Distribution

  • 00889795061980 ()
P10-902-2425

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795061966

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 5
Paragon 28, Inc.
P10-901-RSP5
In Commercial Distribution

  • 00889795061966 ()
P10-901-RSP5

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061942

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 3
Paragon 28, Inc.
P10-901-RSP3
In Commercial Distribution

  • 00889795061942 ()
P10-901-RSP3

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061928

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 1
Paragon 28, Inc.
P10-901-RSP1
In Commercial Distribution

  • 00889795061928 ()
P10-901-RSP1

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061911

APEX 3D-PS Total Ankle Replacement System, Resection Gap Checker, FLAT/Flat-Cut
Paragon 28, Inc.
P10-901-RGF2
In Commercial Distribution

  • 00889795061911 ()
P10-901-RGF2

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795061904

APEX 3D-PS Total Ankle Replacement System, Resection Gap Checker, FLAT/Chamfer-Cut
Paragon 28, Inc.
P10-901-RGF1
In Commercial Distribution

  • 00889795061904 ()
P10-901-RGF1

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795061898

APEX 3D-PS Total Ankle Replacement System, Resection Gap Checker, ARC/Flat-Cut
Paragon 28, Inc.
P10-901-RGA2
In Commercial Distribution

  • 00889795061898 ()
P10-901-RGA2

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795061881

APEX 3D-PS Total Ankle Replacement System, Resection Gap Checker, ARC/Chamfer-Cut
Paragon 28, Inc.
P10-901-RGA1
In Commercial Distribution

  • 00889795061881 ()
P10-901-RGA1

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795061874

APEX 3D-PS Total Ankle Replacement System, Pin Puller
Paragon 28, Inc.
P10-901-PP24
In Commercial Distribution

  • 00889795061874 ()
P10-901-PP24

  • Orthopaedic inorganic implant inserter/extractor, reusable

APEX 3D Total Ankle Replacement System - 00889795061850

APEX 3D-PS Total Ankle Replacement System, Tibial Osteotome, ARC
Paragon 28, Inc.
P10-901-OS01
In Commercial Distribution

  • 00889795061850 ()
P10-901-OS01

  • Orthopaedic osteotome

APEX 3D Total Ankle Replacement System - 00889795061843

APEX 3D-PS Total Ankle Replacement System, T-Handle
Paragon 28, Inc.
P10-901-24TH
In Commercial Distribution

  • 00889795061843 ()
P10-901-24TH

  • Surgical instrument handle, non-torque-limiting

Phantom Hindfoot TTC/TC Nail System - 00889795061836

Phantom TTC Nail, 13.0 X 250mm, RIGHT
Paragon 28, Inc.
P31-330-250R-S
In Commercial Distribution

  • 00889795061836 ()
P31-330-250R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795061829

Phantom TTC Nail, 13.0 X 250mm, LEFT
Paragon 28, Inc.
P31-330-250L-S
In Commercial Distribution

  • 00889795061829 ()
P31-330-250L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795061812

Phantom TTC Nail, 13.0 X 200mm, RIGHT
Paragon 28, Inc.
P31-330-200R-S
In Commercial Distribution

  • 00889795061812 ()
P31-330-200R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795061805

Phantom TTC Nail, 13.0 X 200mm, LEFT
Paragon 28, Inc.
P31-330-200L-S
In Commercial Distribution

  • 00889795061805 ()
P31-330-200L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795136473

Phantom Nail, Crossing Screw, Ø5.0mm x 75mm length, Headless
Paragon 28, Inc.
P32-350-075F
In Commercial Distribution

  • 00889795136473 ()
P32-350-075F

  • Orthopaedic bone screw (non-sliding)

Phantom Hindfoot TTC/TC Nail System - 00889795136466

Phantom Nail, Crossing Screw, Ø5.0mm x 70mm length, Headless
Paragon 28, Inc.
P32-350-070F
In Commercial Distribution

  • 00889795136466 ()
P32-350-070F

  • Orthopaedic bone screw (non-sliding)

Phantom Hindfoot TTC/TC Nail System - 00889795136077

Phantom Nail, Calcaneus Screw, Ø7.2mm x 60mm length, Headless
Paragon 28, Inc.
P31-772-060F
In Commercial Distribution

  • 00889795136077 ()
P31-772-060F

  • Orthopaedic bone screw (non-sliding)

Phantom Hindfoot TTC/TC Nail System - 00889795136053

Phantom Nail, Dynamic Straight, End Cap, 2.5mm thick
Paragon 28, Inc.
P31-100-0003
In Commercial Distribution

  • 00889795136053 ()
P31-100-0003

  • Bone nail end-cap

Phantom Hindfoot TTC/TC Nail System - 00889795136039

Phantom Nail, Calcaneus Screw, Ø7.2mm x 120mm length, Headless
Paragon 28, Inc.
P31-772-120F
In Commercial Distribution

  • 00889795136039 ()
P31-772-120F

  • Orthopaedic bone screw (non-sliding)

Phantom Hindfoot TTC/TC Nail System - 00889795136015

Phantom Nail, Straight, Static Nail, Ø10mm x 150mm
Paragon 28, Inc.
P31-100-1015-01
In Commercial Distribution

  • 00889795136015 ()
P31-100-1015-01

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135995

Phantom 2.0 ActivCore Nail, 13.0 X 200mm
Paragon 28, Inc.
P31-230-2000-S
In Commercial Distribution

  • 00889795135995 ()
P31-230-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135971

Phantom 2.0 ActivCore Nail, 11.5 X 250mm
Paragon 28, Inc.
P31-215-2500-S
In Commercial Distribution

  • 00889795135971 ()
P31-215-2500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135957

Phantom 2.0 ActivCore Nail, 10.0 X 300mm
Paragon 28, Inc.
P31-202-3000-S
In Commercial Distribution

  • 00889795135957 ()
P31-202-3000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135940

Phantom 2.0 ActivCore Nail, 10.0 X 250mm
Paragon 28, Inc.
P31-202-2500-S
In Commercial Distribution

  • 00889795135940 ()
P31-202-2500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135933

Phantom 2.0 ActivCore Nail, 10.0 X 200mm
Paragon 28, Inc.
P31-202-2000-S
In Commercial Distribution

  • 00889795135933 ()
P31-202-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135926

Phantom ActivCore Nail, 13.0 X 250mm
Paragon 28, Inc.
P31-130-2500-S
In Commercial Distribution

  • 00889795135926 ()
P31-130-2500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135919

Phantom ActivCore Nail, 13.0 X 200mm
Paragon 28, Inc.
P31-130-2000-S
In Commercial Distribution

  • 00889795135919 ()
P31-130-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135902

Phantom ActivCore Nail, 13.0 X 175mm
Paragon 28, Inc.
P31-130-1750-S
In Commercial Distribution

  • 00889795135902 ()
P31-130-1750-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135896

Phantom ActivCore Nail, 11.5 X 300mm
Paragon 28, Inc.
P31-115-3000-S
In Commercial Distribution

  • 00889795135896 ()
P31-115-3000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135889

Phantom ActivCore Nail, 11.5 X 250mm
Paragon 28, Inc.
P31-115-2500-S
In Commercial Distribution

  • 00889795135889 ()
P31-115-2500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135872

Phantom ActivCore Nail, 11.5 X 200mm
Paragon 28, Inc.
P31-115-2000-S
In Commercial Distribution

  • 00889795135872 ()
P31-115-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135865

Phantom ActivCore Nail, 11.5 X 175mm
Paragon 28, Inc.
P31-115-1750-S
In Commercial Distribution

  • 00889795135865 ()
P31-115-1750-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135858

Phantom ActivCore Nail, 10.0 X 300mm
Paragon 28, Inc.
P31-102-3000-S
In Commercial Distribution

  • 00889795135858 ()
P31-102-3000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135841

Phantom ActivCore Nail, 10.0 X 250mm
Paragon 28, Inc.
P31-102-2500-S
In Commercial Distribution

  • 00889795135841 ()
P31-102-2500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135834

Phantom ActivCore Nail, 10.0 X 200mm
Paragon 28, Inc.
P31-102-2000-S
In Commercial Distribution

  • 00889795135834 ()
P31-102-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135582

Phantom TTC Nail, 13.0 X 250mm, LEFT
Paragon 28, Inc.
P31-330-250L-S
In Commercial Distribution

  • 00889795135582 ()
P31-330-250L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135568

Phantom TTC Nail, 13.0 X 200mm, LEFT
Paragon 28, Inc.
P31-330-200L-S
In Commercial Distribution

  • 00889795135568 ()
P31-330-200L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135544

Phantom TTC Nail, 13.0 X 175mm, LEFT
Paragon 28, Inc.
P31-330-175L-S
In Commercial Distribution

  • 00889795135544 ()
P31-330-175L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795135520

Phantom TTC Nail, 13.0 X 150mm, LEFT
Paragon 28, Inc.
P31-330-150L-S
In Commercial Distribution

  • 00889795135520 ()
P31-330-150L-S

  • Arthrodesis intramedullary nail, non-distracting

Monster Screw System - 00889795135261

Monster Hindfoot SL Instrument Caddy Tray
Paragon 28, Inc.
P20-900-MH70-5
In Commercial Distribution

  • 00889795135261 ()
P20-900-MH70-5

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795135131

Monster Hindfoot SL Instrument Caddy Lid
Paragon 28, Inc.
P20-900-MH70-4
In Commercial Distribution

  • 00889795135131 ()
P20-900-MH70-4

  • Device sterilization/disinfection container, reusable
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