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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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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

Precision MIS Bunion System - 00889795133076

Screw Caddy Base
Paragon 28, Inc.
P27-900-MISC
In Commercial Distribution

  • 00889795133076 ()
P27-900-MISC

  • Device sterilization/disinfection container, reusable

Precision MIS Bunion System - 00889795133069

Instrument Tray 2
Paragon 28, Inc.
P27-900-MIT2
In Commercial Distribution

  • 00889795133069 ()
P27-900-MIT2

  • Device sterilization/disinfection container, reusable

Precision MIS Bunion System - 00889795133052

Instrument Tray 1
Paragon 28, Inc.
P27-900-MIT1
In Commercial Distribution

  • 00889795133052 ()
P27-900-MIT1

  • Device sterilization/disinfection container, reusable

Precision MIS Bunion System - 00889795133045

Case Base
Paragon 28, Inc.
P27-900-MICB
In Commercial Distribution

  • 00889795133045 ()
P27-900-MICB

  • Device sterilization/disinfection container, reusable

Precision MIS Bunion System - 00889795133038

Case Lid
Paragon 28, Inc.
P27-900-MICL
In Commercial Distribution

  • 00889795133038 ()
P27-900-MICL

  • Device sterilization/disinfection container, reusable

Precision MIS Bunion System - 00889795133021

Curved Elevator
Paragon 28, Inc.
P99-150-2704
In Commercial Distribution

  • 00889795133021 ()
P99-150-2704

  • Periosteal elevator, reusable

Precision MIS Bunion System - 00889795133014

Straight Elevator
Paragon 28, Inc.
P99-150-2703
In Commercial Distribution

  • 00889795133014 ()
P99-150-2703

  • Periosteal elevator, reusable

Precision MIS Bunion System - 00889795133007

K-wire Tube, Ø4.0 Screw
Paragon 28, Inc.
P27-932-4000
In Commercial Distribution

  • 00889795133007 ()
P27-932-4000

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132994

K-wire Tube, Ø3.5 Screw
Paragon 28, Inc.
P27-932-3500
In Commercial Distribution

  • 00889795132994 ()
P27-932-3500

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132987

K-wire Tube, Ø3.0 Screw
Paragon 28, Inc.
P27-932-3000
In Commercial Distribution

  • 00889795132987 ()
P27-932-3000

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132970

Drill Guide Tube, Medial Screw, 4.0 Drill
Paragon 28, Inc.
P27-931-40MD
In Commercial Distribution

  • 00889795132970 ()
P27-931-40MD

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132963

Drill Guide Tube, Medial Screw, 3.5 Drill
Paragon 28, Inc.
P27-931-35MD
In Commercial Distribution

  • 00889795132963 ()
P27-931-35MD

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132956

Drill Guide Tube, Medial Screw, 3.0 Drill
Paragon 28, Inc.
P27-931-30MD
In Commercial Distribution

  • 00889795132956 ()
P27-931-30MD

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132949

Drill Guide Tube, Lateral Screw, 4.0 Drill
Paragon 28, Inc.
P27-931-40LT
In Commercial Distribution

  • 00889795132949 ()
P27-931-40LT

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132932

Drill Guide Tube, Lateral Screw, 3.5 Drill
Paragon 28, Inc.
P27-931-35LT
In Commercial Distribution

  • 00889795132932 ()
P27-931-35LT

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132925

Drill Guide Tube, Lateral Screw, 3.0 Drill
Paragon 28, Inc.
P27-931-30LT
In Commercial Distribution

  • 00889795132925 ()
P27-931-30LT

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132918

Screw Tube, Lateral Screw, Common
Paragon 28, Inc.
P27-930-LAT4
In Commercial Distribution

  • 00889795132918 ()
P27-930-LAT4

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132901

Parallel K-Wire Guide, Handled, Ø3.5 and Ø4.0 Screws
Paragon 28, Inc.
P27-950-3540
In Commercial Distribution

  • 00889795132901 ()
P27-950-3540

  • Surgical drill guide, reusable

Precision MIS Bunion System - 00889795132895

Parallel K-Wire Guide, Handled, Ø3.0 Screw
Paragon 28, Inc.
P27-950-3000
In Commercial Distribution

  • 00889795132895 ()
P27-950-3000

  • Surgical drill guide, reusable

Precision MIS Bunion System - 00889795132888

Drill Guide/Soft Tissue Protector (double sided), Handled, Ø4.0 Screw
Paragon 28, Inc.
P27-943-0040
In Commercial Distribution

  • 00889795132888 ()
P27-943-0040

  • Surgical drill guide, reusable

Precision MIS Bunion System - 00889795132871

Drill Guide/Soft Tissue Protector (double sided), Handled, Ø3.5 Screw
Paragon 28, Inc.
P27-943-0035
In Commercial Distribution

  • 00889795132871 ()
P27-943-0035

  • Surgical drill guide, reusable
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