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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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FJ2000 System - 00889795131225

FJ-2000, Power Cord US Version 100V
Paragon 28, Inc.
P65-002-0003
In Commercial Distribution

  • 00889795131225 ()
P65-002-0003

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131218

FJ-2000, Foot Pedal
Paragon 28, Inc.
P65-002-0002
In Commercial Distribution

  • 00889795131218 ()
P65-002-0002

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131201

FJ-2000, Power Console with Irrigation Pump
Paragon 28, Inc.
P65-002-0001
In Commercial Distribution

  • 00889795131201 ()
P65-002-0001

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131195

FJ-2000, Minimally Invasive Procedure and Open Kit (Sterile)
Paragon 28, Inc.
P65-001-0005-SK
In Commercial Distribution

  • 00889795131195 ()
P65-001-0005-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131188

Saw Blade, 9 x 31 x .051mm, OrthoCircle (Sterile)
Paragon 28, Inc.
P65-151-P300-S
In Commercial Distribution

  • 00889795131188 ()
P65-151-P300-S

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131171

FJ-2000, Open Procedure with Sagittal Saw Kit (Sterile)
Paragon 28, Inc.
P65-001-0004-SK
In Commercial Distribution

  • 00889795131171 ()
P65-001-0004-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131164

FJ-2000, High Speed Handpiece with Sagittal Saw Kit (Sterile)
Paragon 28, Inc.
P65-001-0003-SK
In Commercial Distribution

  • 00889795131164 ()
P65-001-0003-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131157

FJ-2000, MIS Instrument Kit (Sterile)
Paragon 28, Inc.
P65-001-0007-SK
In Commercial Distribution

  • 00889795131157 ()
P65-001-0007-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131140

FJ-2000, MIS Irrigation Kit (Sterile)
Paragon 28, Inc.
P65-001-0006-SK
In Commercial Distribution

  • 00889795131140 ()
P65-001-0006-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131133

Wedge Bone Burr, 4.3 x 13 x 72, AO (Sterile)
Paragon 28, Inc.
P65-108-4313-S
In Commercial Distribution

  • 00889795131133 ()
P65-108-4313-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131126

Wedge Bone Burr, 2.9 x 13 x 72, AO (Sterile)
Paragon 28, Inc.
P65-108-2913-S
In Commercial Distribution

  • 00889795131126 ()
P65-108-2913-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131119

Shannon-style Recta Bone Burr, 3.0 x 30 x 82, AO (Sterile)
Paragon 28, Inc.
P65-105-3030-S
In Commercial Distribution

  • 00889795131119 ()
P65-105-3030-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131102

Shannon-style Recta Bone Burr, 2.2 x 20 x 82, AO (Sterile)
Paragon 28, Inc.
P65-105-2221-S
In Commercial Distribution

  • 00889795131102 ()
P65-105-2221-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131096

Shannon-style Recta Bone Burr, 2.2 x 20 x 72, AO (Sterile)
Paragon 28, Inc.
P65-105-2220-S
In Commercial Distribution

  • 00889795131096 ()
P65-105-2220-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131089

Shannon-style Recta Bone Burr, 2.0 x 20 x 72, AO (Sterile)
Paragon 28, Inc.
P65-105-2020-S
In Commercial Distribution

  • 00889795131089 ()
P65-105-2020-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131072

Shannon-style Recta Bone Burr, 2.0 x 13 x 72, AO (Sterile)
Paragon 28, Inc.
P65-105-2013-S
In Commercial Distribution

  • 00889795131072 ()
P65-105-2013-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131065

Shannon-style Corta Bone Burr, 2.0 x 8 x 72, AO (Sterile)
Paragon 28, Inc.
P65-105-2008-S
In Commercial Distribution

  • 00889795131065 ()
P65-105-2008-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131058

FJ-2000, Minimally Invasive Procedure Kit for Hardware (Sterile)
Paragon 28, Inc.
P65-001-0002-SK
In Commercial Distribution

  • 00889795131058 ()
P65-001-0002-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131041

FJ-2000, MIS Hand Piece and AO Connection Kit (Sterile)
Paragon 28, Inc.
P65-001-0001-SK
In Commercial Distribution

  • 00889795131041 ()
P65-001-0001-SK

  • Surgical power tool system control unit, line-powered

Precision MIS Bunion System - 00889795131034

Ø2.7mm Cannulated Drill for Ø3.5 Screw, Long
Paragon 28, Inc.
P27-110-2720
In Commercial Distribution

  • 00889795131034 ()
P27-110-2720

  • Cannulated surgical drill bit, single-use

Precision MIS Bunion System - 00889795131027

Ø3.0mm Cannulated Drill for Ø4.0 Screw, Long
Paragon 28, Inc.
P27-110-3020
In Commercial Distribution

  • 00889795131027 ()
P27-110-3020

  • Cannulated surgical drill bit, single-use

Monkey Rings™ External Fixation System - 00889795131010

Monkey Rings, Case 2, Tray 3
Paragon 28, Inc.
P45-902-TRY3
In Commercial Distribution

  • 00889795131010 ()
P45-902-TRY3

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130938

Slotted Mallet
Paragon 28, Inc.
P99-150-2006
In Commercial Distribution

  • 00889795130938 ()
P99-150-2006

  • Orthopaedic implantation hammering attachment

Phantom Hindfoot TTC/TC Nail System - 00889795130921

Vice Grips
Paragon 28, Inc.
P99-150-2008
In Commercial Distribution

  • 00889795130921 ()
P99-150-2008

  • Surgical vice grip

Phantom Hindfoot TTC/TC Nail System - 00889795130914

U Handle
Paragon 28, Inc.
P99-150-2007
In Commercial Distribution

  • 00889795130914 ()
P99-150-2007

  • Surgical instrument handle, torque-limiting

Phantom Hindfoot TTC/TC Nail System - 00889795130891

3/16th Adapter
Paragon 28, Inc.
P99-000-316B
In Commercial Distribution

  • 00889795130891 ()
P99-000-316B

  • Surgical screwdriver, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130884

Screw Remover, Small
Paragon 28, Inc.
P31-958-3013
In Commercial Distribution

  • 00889795130884 ()
P31-958-3013

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130877

Screw Remover, Med
Paragon 28, Inc.
P31-958-3012
In Commercial Distribution

  • 00889795130877 ()
P31-958-3012

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130860

Screw Remover, Large
Paragon 28, Inc.
P31-958-3011
In Commercial Distribution

  • 00889795130860 ()
P31-958-3011

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130853

Screw Reamer, Small
Paragon 28, Inc.
P31-958-3003
In Commercial Distribution

  • 00889795130853 ()
P31-958-3003

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130846

Screw Reamer, Med
Paragon 28, Inc.
P31-958-3002
In Commercial Distribution

  • 00889795130846 ()
P31-958-3002

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130839

Screw Reamer, Large
Paragon 28, Inc.
P31-958-3001
In Commercial Distribution

  • 00889795130839 ()
P31-958-3001

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130822

Nail Trephine
Paragon 28, Inc.
P31-958-3000
In Commercial Distribution

  • 00889795130822 ()
P31-958-3000

  • Bone trephine, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130815

Calc Screw Easy Out
Paragon 28, Inc.
P31-958-0030
In Commercial Distribution

  • 00889795130815 ()
P31-958-0030

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130808

Crossing Screw Easy Out
Paragon 28, Inc.
P31-958-0020
In Commercial Distribution

  • 00889795130808 ()
P31-958-0020

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130792

End Cap Easy Out
Paragon 28, Inc.
P31-958-0010
In Commercial Distribution

  • 00889795130792 ()
P31-958-0010

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130785

17mm Hex Nut
Paragon 28, Inc.
P31-958-1003
In Commercial Distribution

  • 00889795130785 ()
P31-958-1003

  • Surgical torque wrench, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130761

17mm Wrench
Paragon 28, Inc.
P31-958-1001
In Commercial Distribution

  • 00889795130761 ()
P31-958-1001

  • Surgical torque wrench, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130754

3.16th T-Handle Non-Ratcheting
Paragon 28, Inc.
P99-000-316C
In Commercial Distribution

  • 00889795130754 ()
P99-000-316C

  • Surgical instrument handle, torque-limiting

Phantom Hindfoot TTC/TC Nail System - 00889795130747

Extender
Paragon 28, Inc.
P31-958-0007
In Commercial Distribution

  • 00889795130747 ()
P31-958-0007

  • Orthopaedic inorganic implant inserter/extractor, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130730

Nail Extraction Hook
Paragon 28, Inc.
P31-958-0005
In Commercial Distribution

  • 00889795130730 ()
P31-958-0005

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130723

Conical Remover
Paragon 28, Inc.
P31-958-0004
In Commercial Distribution

  • 00889795130723 ()
P31-958-0004

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130716

Extractor body
Paragon 28, Inc.
P31-958-0008
In Commercial Distribution

  • 00889795130716 ()
P31-958-0008

  • Orthopaedic inorganic implant inserter/extractor, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130709

Extractor Tip 2 – ActivCore Inner Nail Removal
Paragon 28, Inc.
P31-958-0003
In Commercial Distribution

  • 00889795130709 ()
P31-958-0003

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130693

Extractor Tip 1 – Nail Removal
Paragon 28, Inc.
P31-958-0002
In Commercial Distribution

  • 00889795130693 ()
P31-958-0002

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130686

Explant Attachment 2.0 TTC Only
Paragon 28, Inc.
P31-958-2001
In Commercial Distribution

  • 00889795130686 ()
P31-958-2001

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130679

Large Slap Hammer
Paragon 28, Inc.
P99-150-2005
In Commercial Distribution

  • 00889795130679 ()
P99-150-2005

  • Orthopaedic implantation hammering attachment

JAWS® Nitinol Staple System - 00889795130655

JAWS Staple, 12mm, 12 x 12 Straight
Paragon 28, Inc.
P71-012-1212-S
In Commercial Distribution

  • 00889795130655 ()
P71-012-1212-S

  • Orthopaedic bone staple, non-adjustable

APEX 3D Total Ankle Replacement System - 00889795130648

Total Ankle Instrument, Right Angle Drill, Ø4.15 Bit
Paragon 28, Inc.
P10-854-RAD1-5
In Commercial Distribution

  • 00889795130648 ()
P10-854-RAD1-5

  • Fluted surgical drill bit, reusable

APEX 3D Total Ankle Replacement System - 00889795130631

Total Ankle, Instrument, Right Angle Drill, Left
Paragon 28, Inc.
P10-854-RAD2
In Commercial Distribution

  • 00889795130631 ()
P10-854-RAD2

  • Fluted surgical drill bit, reusable
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