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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 - 00889795062154

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 1, Right
Paragon 28, Inc.
P10-911-TB1R
In Commercial Distribution

  • 00889795062154 ()
P10-911-TB1R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062147

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 1, Left
Paragon 28, Inc.
P10-911-TB1L
In Commercial Distribution

  • 00889795062147 ()
P10-911-TB1L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062130

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 6, Right
Paragon 28, Inc.
P10-910-TB6R
In Commercial Distribution

  • 00889795062130 ()
P10-910-TB6R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062123

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 6, Left
Paragon 28, Inc.
P10-910-TB6L
In Commercial Distribution

  • 00889795062123 ()
P10-910-TB6L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062116

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 5, Right
Paragon 28, Inc.
P10-910-TB5R
In Commercial Distribution

  • 00889795062116 ()
P10-910-TB5R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062109

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 5, Left
Paragon 28, Inc.
P10-910-TB5L
In Commercial Distribution

  • 00889795062109 ()
P10-910-TB5L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062093

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 4, Right
Paragon 28, Inc.
P10-910-TB4R
In Commercial Distribution

  • 00889795062093 ()
P10-910-TB4R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062086

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 4, Left
Paragon 28, Inc.
P10-910-TB4L
In Commercial Distribution

  • 00889795062086 ()
P10-910-TB4L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062079

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 3, Right
Paragon 28, Inc.
P10-910-TB3R
In Commercial Distribution

  • 00889795062079 ()
P10-910-TB3R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062062

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 3, Left
Paragon 28, Inc.
P10-910-TB3L
In Commercial Distribution

  • 00889795062062 ()
P10-910-TB3L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062055

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 2, Right
Paragon 28, Inc.
P10-910-TB2R
In Commercial Distribution

  • 00889795062055 ()
P10-910-TB2R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062048

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 2, Left
Paragon 28, Inc.
P10-910-TB2L
In Commercial Distribution

  • 00889795062048 ()
P10-910-TB2L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062031

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 1, Right
Paragon 28, Inc.
P10-910-TB1R
In Commercial Distribution

  • 00889795062031 ()
P10-910-TB1R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062024

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 1, Left
Paragon 28, Inc.
P10-910-TB1L
In Commercial Distribution

  • 00889795062024 ()
P10-910-TB1L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062017

APEX 3D-PS Total Ankle Replacement System, 3.0 Pin, 316LVM, Fluted, 160mm
Paragon 28, Inc.
P10-902-3016
In Commercial Distribution

  • 00889795062017 ()
P10-902-3016

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795062000

APEX 3D-PS Total Ankle Replacement System, 3.0 Pin, 316LVM, Fluted, 100mm
Paragon 28, Inc.
P10-902-3010
In Commercial Distribution

  • 00889795062000 ()
P10-902-3010

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795061997

APEX 3D-PS Total Ankle Replacement System, 2.4 Shoulder-Thread Pin, 50mm Thread length
Paragon 28, Inc.
P10-902-2450
In Commercial Distribution

  • 00889795061997 ()
P10-902-2450

  • Orthopaedic bone wire

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 - 00889795061973

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 6
Paragon 28, Inc.
P10-901-RSP6
In Commercial Distribution

  • 00889795061973 ()
P10-901-RSP6

  • Bone file/rasp, manual, reusable

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 - 00889795061959

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 4
Paragon 28, Inc.
P10-901-RSP4
In Commercial Distribution

  • 00889795061959 ()
P10-901-RSP4

  • 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 - 00889795061935

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 2
Paragon 28, Inc.
P10-901-RSP2
In Commercial Distribution

  • 00889795061935 ()
P10-901-RSP2

  • 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

APEX 3D S Total Ankle Replacement System - 00889795136817

Short Stem Tibia, Instrument, Drill Bit Cap D9, Short
Paragon 28, Inc.
P11-854-C09S
In Commercial Distribution

  • 00889795136817 ()
P11-854-C09S

  • Cannulated surgical drill bit, single-use

APEX 3D Total Ankle Replacement System - 00889795136800

3.5 Hex Driver, Ball Nose, Short
Paragon 28, Inc.
P99-150-HB35-SHORT
In Commercial Distribution

  • 00889795136800 ()
P99-150-HB35-SHORT

  • Surgical screwdriver, reusable

APEX 3D Total Ankle Replacement System - 00889795136794

3.5 Hex Driver, Ball Nose, Standard
Paragon 28, Inc.
P99-150-HB35
In Commercial Distribution

  • 00889795136794 ()
P99-150-HB35

  • Surgical screwdriver, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795136558

Phantom Hindfoot Nail, Compression End Cap, Long
Paragon 28, Inc.
P31-111-0000-07
In Commercial Distribution

  • 00889795136558 ()
P31-111-0000-07

  • Bone nail end-cap

Phantom Hindfoot TTC/TC Nail System - 00889795136541

Phantom Hindfoot Nail, Compression End Cap, Short
Paragon 28, Inc.
P31-111-0000-03
In Commercial Distribution

  • 00889795136541 ()
P31-111-0000-03

  • Bone nail end-cap
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