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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 - 00889795142634

Tibia, Arc, Left, Size 1, Short, 3DP
Paragon 28, Inc.
P10-100-BL10-S
In Commercial Distribution

  • 00889795142634 ()
P10-100-BL10-S

  • Fixed-bearing total ankle prosthesis

MAVEN™ Patient-Specific Instrumentation - 00889795142504

MAVEN PSI TAR, APEX 3D S AP Tibia Spacer, Right
Paragon 28, Inc.
P11-PSI-R105
In Commercial Distribution

  • 00889795142504 ()
P11-PSI-R105

  • Surgical implant template, single-use

MAVEN™ Patient-Specific Instrumentation - 00889795142498

MAVEN PSI TAR, APEX 3D S AP Tibia Spacer, Left
Paragon 28, Inc.
P11-PSI-L105
In Commercial Distribution

  • 00889795142498 ()
P11-PSI-L105

  • Surgical implant template, single-use

Specialty Instrument, Hardware Removal Caddy - 00889795141590

Hardware Removal Caddy, Lid
Paragon 28, Inc.
SP99-LID-0001
In Commercial Distribution

  • 00889795141590 ()
SP99-LID-0001

  • Device sterilization/disinfection container, reusable

Specialty Instrument, Hardware Removal Caddy - 00889795141583

Hardware Removal Caddy, Base
Paragon 28, Inc.
SP99-CAD-0001
In Commercial Distribution

  • 00889795141583 ()
SP99-CAD-0001

  • Device sterilization/disinfection container, reusable

Monkey Bars™ Pin to Bar External Fixation System - 00889795141576

175mm X 210mm Aluminum Kickstand
Paragon 28, Inc.
P85-510-175U
In Commercial Distribution

  • 00889795141576 ()
P85-510-175U

  • External orthopaedic fixation system, single-use

Grappler Interference Screw System - 00889795141538

PCFD Tether, System Tray
Paragon 28, Inc.
P62-CAD-0001
In Commercial Distribution

  • 00889795141538 ()
P62-CAD-0001

  • Device sterilization/disinfection container, reusable

Grappler Interference Screw System - 00889795141491

PCFD Tether, Sinus Tarsai Dilator
Paragon 28, Inc.
P62-910-0009
In Commercial Distribution

  • 00889795141491 ()
P62-910-0009

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Grappler Interference Screw System - 00889795141446

PCFD Tether, Talar Carriage Assembly
Paragon 28, Inc.
P62-910-0002
In Commercial Distribution

  • 00889795141446 ()
P62-910-0002

  • Surgical drill guide, reusable

Phantom® Fibula Nail System - 00889795141248

Removal Hook, Pin
Paragon 28, Inc.
P36-970-0007
In Commercial Distribution

  • 00889795141248 ()
P36-970-0007

  • Bone hook

APEX 3D Total Ankle Replacement System - 00889795141200

Total Ankle Instrument, Ø4.15 Drill Cap
Paragon 28, Inc.
P10-854-C042
In Commercial Distribution

  • 00889795141200 ()
P10-854-C042

  • Surgical drill guide, single-use

APEX 3D S Total Ankle Replacement System - 00889795140692

Short Stem Tibia System, Drill Caddy
Paragon 28, Inc.
P11-900-0003
In Commercial Distribution

  • 00889795140692 ()
P11-900-0003

  • Device sterilization/disinfection container, reusable

APEX 3D S Total Ankle Replacement System - 00889795140678

Short Stem Tibia System, Tray 1
Paragon 28, Inc.
P11-900-0001
In Commercial Distribution

  • 00889795140678 ()
P11-900-0001

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795140654

Complex Total Ankle Instrument, Shim, Talar
Paragon 28, Inc.
P11-TSH-2530
In Commercial Distribution

  • 00889795140654 ()
P11-TSH-2530

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D S Total Ankle Replacement System - 00889795140517

Short Stem Tibia, Instrument, Impaction Protector (Size 1+2)
Paragon 28, Inc.
P11-851-TP12
In Commercial Distribution

  • 00889795140517 ()
P11-851-TP12

  • Orthopaedic implant impactor, single-use

APEX 3D S Total Ankle Replacement System - 00889795140494

Short Stem Tibia, Instrument, Forked Paddle, Flat
Paragon 28, Inc.
P11-851-P041
In Commercial Distribution

  • 00889795140494 ()
P11-851-P041

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

APEX 3D S Total Ankle Replacement System - 00889795140487

Short Stem Tibia, Instrument, Flat Paddle - 2
Paragon 28, Inc.
P11-851-P032
In Commercial Distribution

  • 00889795140487 ()
P11-851-P032

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

APEX 3D S Total Ankle Replacement System - 00889795140463

Short Stem Tibia, Instrument, Implantation Paddle
Paragon 28, Inc.
P11-851-P021
In Commercial Distribution

  • 00889795140463 ()
P11-851-P021

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

APEX 3D S Total Ankle Replacement System - 00889795140456

Short Stem Tibia, Instrument, Forked Paddle, Arc
Paragon 28, Inc.
P11-851-P051
In Commercial Distribution

  • 00889795140456 ()
P11-851-P051

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

APEX 3D S Total Ankle Replacement System - 00889795140432

Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 5 - FLAT
Paragon 28, Inc.
P11-810-TUF5
In Commercial Distribution

  • 00889795140432 ()
P11-810-TUF5

  • Surgical drill guide, reusable
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