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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® Fibula Nail System - 00889795133724

3.4mm x 130mm, Right, Ti, Fibula Nail, Sterile
Paragon 28, Inc.
P36-134-130R-S
In Commercial Distribution

  • 00889795133724 ()
P36-134-130R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom® Fibula Nail System - 00889795133717

3.4mm x 270mm, Left, Ti, Fibula Nail, Sterile
Paragon 28, Inc.
P36-134-270L-S
In Commercial Distribution

  • 00889795133717 ()
P36-134-270L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom® Fibula Nail System - 00889795133700

3.4mm x 180mm, Left, Ti, Fibula Nail, Sterile
Paragon 28, Inc.
P36-134-180L-S
In Commercial Distribution

  • 00889795133700 ()
P36-134-180L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom® Fibula Nail System - 00889795133694

3.4mm x 130mm, Left, Ti, Fibula Nail, Sterile
Paragon 28, Inc.
P36-134-130L-S
In Commercial Distribution

  • 00889795133694 ()
P36-134-130L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom® Fibula Nail System - 00889795133687

2.8mm x 180mm, Right, Ti, Fibula Nail, Sterile
Paragon 28, Inc.
P36-128-180R-S
In Commercial Distribution

  • 00889795133687 ()
P36-128-180R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom® Fibula Nail System - 00889795133670

2.8mm x 130mm, Right, Ti, Fibula Nail, Sterile
Paragon 28, Inc.
P36-128-130R-S
In Commercial Distribution

  • 00889795133670 ()
P36-128-130R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom® Fibula Nail System - 00889795133663

2.8mm x 180mm, Left, Ti, Fibula Nail, Sterile
Paragon 28, Inc.
P36-128-180L-S
In Commercial Distribution

  • 00889795133663 ()
P36-128-180L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom® Fibula Nail System - 00889795133656

2.8mm x 130mm, Left, Ti, Fibula Nail, Sterile
Paragon 28, Inc.
P36-128-130L-S
In Commercial Distribution

  • 00889795133656 ()
P36-128-130L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795133649

Vice Grip Attachment
Paragon 28, Inc.
P99-150-2008-10
In Commercial Distribution

  • 00889795133649 ()
P99-150-2008-10

  • Surgical vice grip

Phantom Hindfoot TTC/TC Nail System - 00889795133632

Phantom Hindfoot Explant Tip Caddy Lid
Paragon 28, Inc.
P31-906-EXTT-1
In Commercial Distribution

  • 00889795133632 ()
P31-906-EXTT-1

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795133618

8mm Wrench
Paragon 28, Inc.
P31-958-1002
In Commercial Distribution

  • 00889795133618 ()
P31-958-1002

  • Surgical torque wrench, reusable

Monkey Rings™ External Fixation System - 00889795133595

Connection Bolt, 25mm
Paragon 28, Inc.
P45-914-0004
In Commercial Distribution

  • 00889795133595 ()
P45-914-0004

  • External orthopaedic fixation system, single-use

APEX 3D Total Ankle Replacement System - 00889795133571

Total Ankle Instrument, Tibia Trial, Flat, Size 6
Paragon 28, Inc.
P10-813-TB6U
In Commercial Distribution

  • 00889795133571 ()
P10-813-TB6U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133564

Total Ankle Instrument, Tibia Trial, Flat, Size 5
Paragon 28, Inc.
P10-813-TB5U
In Commercial Distribution

  • 00889795133564 ()
P10-813-TB5U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133557

Total Ankle Instrument, Tibia Trial, Flat, Size 4
Paragon 28, Inc.
P10-813-TB4U
In Commercial Distribution

  • 00889795133557 ()
P10-813-TB4U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133540

Total Ankle Instrument, Tibia Trial, Flat, Size 3
Paragon 28, Inc.
P10-813-TB3U
In Commercial Distribution

  • 00889795133540 ()
P10-813-TB3U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133533

Total Ankle Instrument, Tibia Trial, Flat, Size 2
Paragon 28, Inc.
P10-813-TB2U
In Commercial Distribution

  • 00889795133533 ()
P10-813-TB2U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133526

Total Ankle Instrument, Tibia Trial, Flat, Size 1
Paragon 28, Inc.
P10-813-TB1U
In Commercial Distribution

  • 00889795133526 ()
P10-813-TB1U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133519

Total Ankle Instrument, Tibia Trial, Arc, Size 6
Paragon 28, Inc.
P10-812-TB6U
In Commercial Distribution

  • 00889795133519 ()
P10-812-TB6U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133502

Total Ankle Instrument, Tibia Trial, Arc, Size 5
Paragon 28, Inc.
P10-812-TB5U
In Commercial Distribution

  • 00889795133502 ()
P10-812-TB5U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133496

Total Ankle Instrument, Tibia Trial, Arc, Size 4
Paragon 28, Inc.
P10-812-TB4U
In Commercial Distribution

  • 00889795133496 ()
P10-812-TB4U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133489

Total Ankle Instrument, Tibia Trial, Arc, Size 3
Paragon 28, Inc.
P10-812-TB3U
In Commercial Distribution

  • 00889795133489 ()
P10-812-TB3U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133472

Total Ankle Instrument, Tibia Trial, Arc, Size 2
Paragon 28, Inc.
P10-812-TB2U
In Commercial Distribution

  • 00889795133472 ()
P10-812-TB2U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133465

Total Ankle Instrument, Tibia Trial, Arc, Size 1
Paragon 28, Inc.
P10-812-TB1U
In Commercial Distribution

  • 00889795133465 ()
P10-812-TB1U

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795133458

Total Ankle Instrument, Linear Guide
Paragon 28, Inc.
P10-854-LG10
In Commercial Distribution

  • 00889795133458 ()
P10-854-LG10

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795133441

Total Ankle Instrument, Wrench
Paragon 28, Inc.
P10-854-WR01
In Commercial Distribution

  • 00889795133441 ()
P10-854-WR01

  • Surgical torque wrench, reusable

APEX 3D Total Ankle Replacement System - 00889795133434

Total Ankle Instrument, Arc Polishing Block, Size 6
Paragon 28, Inc.
P10-842-AC06
In Commercial Distribution

  • 00889795133434 ()
P10-842-AC06

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795133427

Total Ankle Instrument, Arc Polishing Block, Size 5
Paragon 28, Inc.
P10-842-AC05
In Commercial Distribution

  • 00889795133427 ()
P10-842-AC05

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795133410

Total Ankle Instrument, Arc Polishing Block, Size 4
Paragon 28, Inc.
P10-842-AC04
In Commercial Distribution

  • 00889795133410 ()
P10-842-AC04

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795133403

Total Ankle Instrument, Arc Polishing Block, Size 3
Paragon 28, Inc.
P10-842-AC03
In Commercial Distribution

  • 00889795133403 ()
P10-842-AC03

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795133397

Total Ankle Instrument, Arc Polishing Block, Size 2
Paragon 28, Inc.
P10-842-AC02
In Commercial Distribution

  • 00889795133397 ()
P10-842-AC02

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795133380

Total Ankle Instrument, Arc Polishing Block, Size 1
Paragon 28, Inc.
P10-842-AC01
In Commercial Distribution

  • 00889795133380 ()
P10-842-AC01

  • Surgical drill guide, reusable

Phantom® Fibula Nail System - 00889795133335

20mm End Cap, Ti
Paragon 28, Inc.
P36-503-0020
In Commercial Distribution

  • 00889795133335 ()
P36-503-0020

  • Bone nail end-cap

Phantom® Fibula Nail System - 00889795133328

10mm End Cap, Ti
Paragon 28, Inc.
P36-503-0010
In Commercial Distribution

  • 00889795133328 ()
P36-503-0010

  • Bone nail end-cap

Phantom® Fibula Nail System - 00889795133311

5mm End Cap, Ti
Paragon 28, Inc.
P36-503-0005
In Commercial Distribution

  • 00889795133311 ()
P36-503-0005

  • Bone nail end-cap

Phantom® Fibula Nail System - 00889795133304

1mm End Cap, Ti
Paragon 28, Inc.
P36-503-0001
In Commercial Distribution

  • 00889795133304 ()
P36-503-0001

  • Bone nail end-cap

FJ2000 System - 00889795133113

Shannon-style Recta Bone Burr, 3.0 x 30 x 100, AO (Sterile)
Paragon 28, Inc.
P65-105-3031-S
In Commercial Distribution

  • 00889795133113 ()
P65-105-3031-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795133106

Shannon-style Corta Bone Burr, 3.0 x 20 x 100, AO (Sterile)
Paragon 28, Inc.
P65-105-3020-S
In Commercial Distribution

  • 00889795133106 ()
P65-105-3020-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795133090

Shannon-style Corta Bone Burr, 2.0 x 20 x 72 AO (sterile)
Paragon 28, Inc.
P65-105-2021-S
In Commercial Distribution

  • 00889795133090 ()
P65-105-2021-S

  • Orthopaedic bur, single-use

Precision MIS Bunion System - 00889795133083

Screw Caddy Lid
Paragon 28, Inc.
P27-900-MISL
In Commercial Distribution

  • 00889795133083 ()
P27-900-MISL

  • Device sterilization/disinfection container, reusable
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