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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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Phantom Hindfoot TTC/TC Nail System - 00889795098238

Phantom Hindfoot Nail, Internal Compression Screw
Paragon 28, Inc.
P31-101-0000-03
In Commercial Distribution

  • 00889795098238 ()
P31-101-0000-03

  • Bone-nailing compression screw

Phantom Hindfoot TTC/TC Nail System - 00889795098221

Phantom Nail, Crossing Screw, Ø5.0mm x 70mm length, Headed
Paragon 28, Inc.
P32-450-070F
In Commercial Distribution

  • 00889795098221 ()
P32-450-070F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Phantom Hindfoot TTC/TC Nail System - 00889795098214

Phantom Nail, Crossing Screw, Ø5.0mm x 68mm length, Headed
Paragon 28, Inc.
P32-450-068F
In Commercial Distribution

  • 00889795098214 ()
P32-450-068F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Phantom Hindfoot TTC/TC Nail System - 00889795098207

Phantom Nail, Crossing Screw, Ø5.0mm x 66mm length, Headed
Paragon 28, Inc.
P32-450-066F
In Commercial Distribution

  • 00889795098207 ()
P32-450-066F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Phantom Hindfoot TTC/TC Nail System - 00889795098191

Phantom Nail, Crossing Screw, Ø5.0mm x 64mm length, Headed
Paragon 28, Inc.
P32-450-064F
In Commercial Distribution

  • 00889795098191 ()
P32-450-064F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Phantom Hindfoot TTC/TC Nail System - 00889795098184

Phantom Nail, Crossing Screw, Ø5.0mm x 62mm length, Headed
Paragon 28, Inc.
P32-450-062F
In Commercial Distribution

  • 00889795098184 ()
P32-450-062F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Phantom Hindfoot TTC/TC Nail System - 00889795098177

Phantom Nail, Calcaneus Screw, Ø7.2mm x 55mm length, Headless
Paragon 28, Inc.
P31-772-055F
In Commercial Distribution

  • 00889795098177 ()
P31-772-055F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Phantom Hindfoot TTC/TC Nail System - 00889795098160

Phantom Nail, Calcaneus Screw, Ø7.2mm x 50mm length, Headless
Paragon 28, Inc.
P31-772-050F
In Commercial Distribution

  • 00889795098160 ()
P31-772-050F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Phantom Hindfoot TTC/TC Nail System - 00889795098153

Phantom Nail, Calcaneus Screw, Ø7.2mm x 45mm length, Headless
Paragon 28, Inc.
P31-772-045F
In Commercial Distribution

  • 00889795098153 ()
P31-772-045F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Phantom Hindfoot TTC/TC Nail System - 00889795098146

Phantom Screw Driver Attachment, Cannulated, 3/16" Sq. Connection, TX-30 x 85mm
Paragon 28, Inc.
P31-190-TX30-09
In Commercial Distribution

  • 00889795098146 ()
P31-190-TX30-09

  • Bone nail driver

Phantom Hindfoot TTC/TC Nail System - 00889795098139

Screw Driver Attachment, Solid, 3/16" Sq. Connection, TX-20 x 160mm
Paragon 28, Inc.
P99-191-TX20-16
In Commercial Distribution

  • 00889795098139 ()
P99-191-TX20-16

  • Bone nail driver

Phantom Hindfoot TTC/TC Nail System - 00889795098122

Phantom Hindfoot Depth Gauge, Cannulated
Paragon 28, Inc.
P31-957-0002
In Commercial Distribution

  • 00889795098122 ()
P31-957-0002

  • Surgical depth gauge, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098115

Phantom Hindfoot Depth Gauge, Solid
Paragon 28, Inc.
P31-957-0001
In Commercial Distribution

  • 00889795098115 ()
P31-957-0001

  • Surgical depth gauge, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795098108

Drill, 3.8 X 250mm Drill, Solid, Trocar Tip, 3/16" Sq. Connection
Paragon 28, Inc.
P99-100-3825
In Commercial Distribution

  • 00889795098108 ()
P99-100-3825

  • Fluted surgical drill bit, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795097712

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

  • 00889795097712 ()
P31-102-2000-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795097699

Phantom TC Nail, 13.0 X 250mm
Paragon 28, Inc.
P31-430-2500-S
In Commercial Distribution

  • 00889795097699 ()
P31-430-2500-S

  • Arthrodesis intramedullary nail, non-distracting

APEX 3D Total Ankle Replacement System - 00889795097538

APEX 3D™ Tibia, Flat, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-101-BR6S-S
In Commercial Distribution

  • 00889795097538 ()
P10-101-BR6S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795097514

APEX 3D™ Tibia, Arc, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-100-BR6S-S
In Commercial Distribution

  • 00889795097514 ()
P10-100-BR6S-S

  • Fixed-bearing total ankle prosthesis

Baby Gorilla®/Gorilla® Plating System - 00889795097491

AVITRAC™ Core, MTP Reamer, Ø13 mm
Paragon 28, Inc.
P01-901-1301
In Commercial Distribution

  • 00889795097491 ()
P01-901-1301

  • Bone-resection orthopaedic reamer, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795097477

AVITRAC™ Core, MTP Reamer, Ø9 mm
Paragon 28, Inc.
P01-901-0901
In Commercial Distribution

  • 00889795097477 ()
P01-901-0901

  • Bone-resection orthopaedic reamer, reusable

Monster® Screw System - 00889795097453

Precision® JMF™ Screw Washer Caddy Base
Paragon 28, Inc.
P25-900-WSCD
In Commercial Distribution

  • 00889795097453 ()
P25-900-WSCD

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795072344

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 18MM, NEUTRAL
Paragon 28, Inc.
P10-310-I218-S
In Commercial Distribution

  • 00889795072344 ()
P10-310-I218-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795072320

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 16MM, NEUTRAL
Paragon 28, Inc.
P10-310-I216-S
In Commercial Distribution

  • 00889795072320 ()
P10-310-I216-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795072306

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 14MM, NEUTRAL
Paragon 28, Inc.
P10-310-I214-S
In Commercial Distribution

  • 00889795072306 ()
P10-310-I214-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795072283

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 12MM, NEUTRAL
Paragon 28, Inc.
P10-310-I212-S
In Commercial Distribution

  • 00889795072283 ()
P10-310-I212-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795072276

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 11MM, NEUTRAL
Paragon 28, Inc.
P10-310-I211-S
In Commercial Distribution

  • 00889795072276 ()
P10-310-I211-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795072269

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 10MM, NEUTRAL
Paragon 28, Inc.
P10-310-I210-S
In Commercial Distribution

  • 00889795072269 ()
P10-310-I210-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795072252

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 9MM, NEUTRAL
Paragon 28, Inc.
P10-310-I209-S
In Commercial Distribution

  • 00889795072252 ()
P10-310-I209-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795072245

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 8MM, NEUTRAL
Paragon 28, Inc.
P10-310-I208-S
In Commercial Distribution

  • 00889795072245 ()
P10-310-I208-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795072238

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 7MM, NEUTRAL
Paragon 28, Inc.
P10-310-I207-S
In Commercial Distribution

  • 00889795072238 ()
P10-310-I207-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795072221

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 6MM, NEUTRAL
Paragon 28, Inc.
P10-310-I206-S
In Commercial Distribution

  • 00889795072221 ()
P10-310-I206-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795071019

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 20MM, NEUTRAL
Paragon 28, Inc.
P10-310-I120-S
In Commercial Distribution

  • 00889795071019 ()
P10-310-I120-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070999

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 18MM, NEUTRAL
Paragon 28, Inc.
P10-310-I118-S
In Commercial Distribution

  • 00889795070999 ()
P10-310-I118-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070975

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 16MM, NEUTRAL
Paragon 28, Inc.
P10-310-I116-S
In Commercial Distribution

  • 00889795070975 ()
P10-310-I116-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070951

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 14MM, NEUTRAL
Paragon 28, Inc.
P10-310-I114-S
In Commercial Distribution

  • 00889795070951 ()
P10-310-I114-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070937

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 12MM, NEUTRAL
Paragon 28, Inc.
P10-310-I112-S
In Commercial Distribution

  • 00889795070937 ()
P10-310-I112-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070920

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 11MM, NEUTRAL
Paragon 28, Inc.
P10-310-I111-S
In Commercial Distribution

  • 00889795070920 ()
P10-310-I111-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070913

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 10MM, NEUTRAL
Paragon 28, Inc.
P10-310-I110-S
In Commercial Distribution

  • 00889795070913 ()
P10-310-I110-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070906

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 9MM, NEUTRAL
Paragon 28, Inc.
P10-310-I109-S
In Commercial Distribution

  • 00889795070906 ()
P10-310-I109-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070890

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 8MM, NEUTRAL
Paragon 28, Inc.
P10-310-I108-S
In Commercial Distribution

  • 00889795070890 ()
P10-310-I108-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070883

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 7MM, NEUTRAL
Paragon 28, Inc.
P10-310-I107-S
In Commercial Distribution

  • 00889795070883 ()
P10-310-I107-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070876

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 6MM, NEUTRAL
Paragon 28, Inc.
P10-310-I106-S
In Commercial Distribution

  • 00889795070876 ()
P10-310-I106-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795064110

Steinmann Pin, 316LVM, Smooth, Ø2.4x110mm
Paragon 28, Inc.
P99-160-2411
In Commercial Distribution

  • 00889795064110 ()
P99-160-2411

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795064103

3.5MM Hex Screw Driver, 225mm Length
Paragon 28, Inc.
P99-150-HX35
In Commercial Distribution

  • 00889795064103 ()
P99-150-HX35

  • Surgical screwdriver, reusable

APEX 3D Total Ankle Replacement System - 00889795064097

Rasp, General
Paragon 28, Inc.
P99-150-0105
In Commercial Distribution

  • 00889795064097 ()
P99-150-0105

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795064080

APEX 3D-PS Total Ankle Replacement System, Talus Trial Handling Tool
Paragon 28, Inc.
P10-953-TL01
In Commercial Distribution

  • 00889795064080 ()
P10-953-TL01

  • Surgical instrument handle, non-torque-limiting

APEX 3D Total Ankle Replacement System - 00889795064073

APEX 3D-PS Total Ankle Replacement System, Poly Trial Handling Tool
Paragon 28, Inc.
P10-953-IN01
In Commercial Distribution

  • 00889795064073 ()
P10-953-IN01

  • Surgical instrument handle, non-torque-limiting

APEX 3D Total Ankle Replacement System - 00889795064066

APEX 3D-PS Total Ankle Replacement System, Talus Impaction Handle
Paragon 28, Inc.
P10-952-TL00
In Commercial Distribution

  • 00889795064066 ()
P10-952-TL00

  • Surgical instrument handle, non-torque-limiting

APEX 3D Total Ankle Replacement System - 00889795064059

APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Right, Size 6
Paragon 28, Inc.
P10-951-TPR6
In Commercial Distribution

  • 00889795064059 ()
P10-951-TPR6

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795064042

APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Right, Size 5
Paragon 28, Inc.
P10-951-TPR5
In Commercial Distribution

  • 00889795064042 ()
P10-951-TPR5

  • Bone-coring punch, reusable
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