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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 - 00889795098955

APEX 3D-PS Total Ankle Replacement System, Alignment, Tray
Paragon 28, Inc.
P10-900-0001
In Commercial Distribution

  • 00889795098955 ()
P10-900-0001

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795098948

Total Ankle, Instrument, Alignment, Guide, PSI Alignment Rod
Paragon 28, Inc.
P10-941-PSI1
In Commercial Distribution

  • 00889795098948 ()
P10-941-PSI1

  • Orthopaedic fixation implant alignment tool

APEX 3D Total Ankle Replacement System - 00889795098924

Total Ankle, Instrument, Socket Driver
Paragon 28, Inc.
P10-910-SCKT
In Commercial Distribution

  • 00889795098924 ()
P10-910-SCKT

  • Surgical screwdriver, reusable

Dynamic Syndesmosis - 00889795098474

Dynamic Syndesmosis Screw Ø4.2 X 55mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1755-S
In Commercial Distribution

  • 00889795098474 ()
P80-142-1755-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Dynamic Syndesmosis - 00889795098443

Dynamic Syndesmosis Screw Ø4.2 X 40mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1740-S
In Commercial Distribution

  • 00889795098443 ()
P80-142-1740-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Dynamic Syndesmosis - 00889795098429

Dynamic Syndesmosis Screw Ø4.2 X 55mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1455-S
In Commercial Distribution

  • 00889795098429 ()
P80-142-1455-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Dynamic Syndesmosis - 00889795098405

Dynamic Syndesmosis Screw Ø4.2 X 45mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1445-S
In Commercial Distribution

  • 00889795098405 ()
P80-142-1445-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Phantom Hindfoot TTC/TC Nail System - 00889795098382

Phantom Hindfoot TTC/TC Nail, Reamer Caddy, Case 2 of 3
Paragon 28, Inc.
P31-902-RMCD
In Commercial Distribution

  • 00889795098382 ()
P31-902-RMCD

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098368

Phantom Hindfoot TTC/TC Nail, Tray 1, Case 2 of 3
Paragon 28, Inc.
P31-902-TRY1
In Commercial Distribution

  • 00889795098368 ()
P31-902-TRY1

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098344

Phantom Hindfoot TTC/TC Nail, Caddy 2 Base, Case 3 of 3
Paragon 28, Inc.
P31-903-CBS2
In Commercial Distribution

  • 00889795098344 ()
P31-903-CBS2

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098337

Phantom Hindfoot TTC/TC Nail, Caddy 2 Lid, Case 3 of 3
Paragon 28, Inc.
P31-903-CLD2
In Commercial Distribution

  • 00889795098337 ()
P31-903-CLD2

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098313

Phantom Hindfoot TTC/TC Nail, Caddy 1 Lid, Case 3 of 3
Paragon 28, Inc.
P31-903-C1LD
In Commercial Distribution

  • 00889795098313 ()
P31-903-C1LD

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098092

Explant Attachment, Phantom Hindfoot
Paragon 28, Inc.
P31-958-0001
In Commercial Distribution

  • 00889795098092 ()
P31-958-0001

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795098085

Bolt Driver Attachment, 8mm Hex, Phantom Hindfoot
Paragon 28, Inc.
P31-950-9000
In Commercial Distribution

  • 00889795098085 ()
P31-950-9000

  • Bone nail driver

Phantom Hindfoot TTC/TC Nail System - 00889795098078

Ghost Outrigger Homerun Guidewire Sleeve, 7.0mm
Paragon 28, Inc.
P31-950-1001-23
In Commercial Distribution

  • 00889795098078 ()
P31-950-1001-23

  • Orthopaedic implantation sleeve, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098061

Ghost Outrigger Homerun Guidewire Sleeve, 5.5mm
Paragon 28, Inc.
P31-950-1001-16
In Commercial Distribution

  • 00889795098061 ()
P31-950-1001-16

  • Orthopaedic implantation sleeve, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098054

Ghost Outrigger Homerun Guidewire Sleeve, 4.0mm
Paragon 28, Inc.
P31-950-1001-14
In Commercial Distribution

  • 00889795098054 ()
P31-950-1001-14

  • Orthopaedic implantation sleeve, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098047

Ghost Outrigger Guide, Homerun Screw Arm
Paragon 28, Inc.
P31-950-1000
In Commercial Distribution

  • 00889795098047 ()
P31-950-1000

  • Orthopaedic implant aiming arm

Phantom Hindfoot TTC/TC Nail System - 00889795098030

Ghost Outrigger Guide, Subtalar Arm
Paragon 28, Inc.
P31-950-0050
In Commercial Distribution

  • 00889795098030 ()
P31-950-0050

  • Orthopaedic implant aiming arm

Phantom Hindfoot TTC/TC Nail System - 00889795098023

Ghost Outrigger Calc Screw Guide, 7.2mm
Paragon 28, Inc.
P31-950-0057
In Commercial Distribution

  • 00889795098023 ()
P31-950-0057

  • Orthopaedic implantation sleeve, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098016

Ghost Outrigger Subtalar Screw Guide, 7.2mm
Paragon 28, Inc.
P31-950-0009
In Commercial Distribution

  • 00889795098016 ()
P31-950-0009

  • Orthopaedic implantation sleeve, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098009

Ghost Outrigger Subtalar Drill Guide, 7.2mm
Paragon 28, Inc.
P31-950-0008
In Commercial Distribution

  • 00889795098009 ()
P31-950-0008

  • Surgical drill guide, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097996

Ghost Outrigger Calc Screw Guide, 7.2mm, Active
Paragon 28, Inc.
P31-950-0007
In Commercial Distribution

  • 00889795097996 ()
P31-950-0007

  • Orthopaedic implantation sleeve, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097989

Phantom Hindfoot Flexible Reamer Shaft, 345mm
Paragon 28, Inc.
P31-954-0345
In Commercial Distribution

  • 00889795097989 ()
P31-954-0345

  • Medullary canal orthopaedic reamer, flexible

Phantom Hindfoot TTC/TC Nail System - 00889795097972

Phantom Hindfoot Ball Tipped Guide Rod, 3.0 x 550mm
Paragon 28, Inc.
P31-955-1550
In Commercial Distribution

  • 00889795097972 ()
P31-955-1550

  • Orthopaedic guidewire, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795097965

Phantom Hindfoot TTC/TC Nail, Tray 2, Case 1 of 3
Paragon 28, Inc.
P31-901-TRY2
In Commercial Distribution

  • 00889795097965 ()
P31-901-TRY2

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097958

Phantom Hindfoot TTC/TC Nail, Tray 1, Case 1 of 3
Paragon 28, Inc.
P31-901-TRY1
In Commercial Distribution

  • 00889795097958 ()
P31-901-TRY1

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097941

Phantom Hindfoot TTC/TC Nail, Case Base, Case 1 of 3
Paragon 28, Inc.
P31-901-BASE
In Commercial Distribution

  • 00889795097941 ()
P31-901-BASE

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097934

Phantom Hindfoot TTC/TC Nail, Case Lid
Paragon 28, Inc.
P31-901-LID
In Commercial Distribution

  • 00889795097934 ()
P31-901-LID

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097927

Tissue Protector
Paragon 28, Inc.
P31-956-0001
In Commercial Distribution

  • 00889795097927 ()
P31-956-0001

  • Orthopaedic implantation sleeve, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097910

7.0 x 20cm Drill
Paragon 28, Inc.
P99-110-7019
In Commercial Distribution

  • 00889795097910 ()
P99-110-7019

  • Cannulated surgical drill bit, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795097903

PRECISION® Parallel Offset Guide
Paragon 28, Inc.
P31-951-1000
In Commercial Distribution

  • 00889795097903 ()
P31-951-1000

  • Surgical drill guide, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097897

PRECISION® Guide Alignment Fin
Paragon 28, Inc.
P31-951-0103
In Commercial Distribution

  • 00889795097897 ()
P31-951-0103

  • Orthopaedic fixation implant alignment tool

Phantom Hindfoot TTC/TC Nail System - 00889795097880

PRECISION® Guide Tube
Paragon 28, Inc.
P31-951-0102
In Commercial Distribution

  • 00889795097880 ()
P31-951-0102

  • Orthopaedic implant aiming arm

Phantom Hindfoot TTC/TC Nail System - 00889795097873

PRECISION® Guide Arm
Paragon 28, Inc.
P31-951-0101
In Commercial Distribution

  • 00889795097873 ()
P31-951-0101

  • Orthopaedic implant aiming arm

Phantom Hindfoot TTC/TC Nail System - 00889795097866

PRECISION® Guide Sphere Wire
Paragon 28, Inc.
P31-951-0199
In Commercial Distribution

  • 00889795097866 ()
P31-951-0199

  • Orthopaedic guidewire, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795097859

PRECISION® Guide Drill Pin, 3.0 X 320mm
Paragon 28, Inc.
P31-951-3032
In Commercial Distribution

  • 00889795097859 ()
P31-951-3032

  • Orthopaedic guidewire, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795097842

Wire Tube, Cap
Paragon 28, Inc.
P31-941-0000
In Commercial Distribution

  • 00889795097842 ()
P31-941-0000

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097835

Wire Tube, 3.0 x 320mm
Paragon 28, Inc.
P31-941-0340
In Commercial Distribution

  • 00889795097835 ()
P31-941-0340

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097828

Wire Tube, 2.3 x 300mm
Paragon 28, Inc.
P31-941-0320
In Commercial Distribution

  • 00889795097828 ()
P31-941-0320

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097811

Wire Tube, 2.0 x 200mm
Paragon 28, Inc.
P31-941-0200
In Commercial Distribution

  • 00889795097811 ()
P31-941-0200

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795097804

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

  • 00889795097804 ()
P31-130-2500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097798

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

  • 00889795097798 ()
P31-130-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097781

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

  • 00889795097781 ()
P31-130-1750-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097774

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

  • 00889795097774 ()
P31-115-3000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097767

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

  • 00889795097767 ()
P31-115-2500-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097750

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

  • 00889795097750 ()
P31-115-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097743

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

  • 00889795097743 ()
P31-115-1750-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097736

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

  • 00889795097736 ()
P31-102-3000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097729

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

  • 00889795097729 ()
P31-102-2500-S

  • Arthrodesis intramedullary nail, non-distracting
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