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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 S Total Ankle Replacement System - 00889795140425

Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 4 - FLAT
Paragon 28, Inc.
P11-810-TUF4
In Commercial Distribution

  • 00889795140425 ()
P11-810-TUF4

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795137241

APEX 3D-PS Total Ankle Replacement System, Case Short Base
Paragon 28, Inc.
P10-900-CSSB
In Commercial Distribution

  • 00889795137241 ()
P10-900-CSSB

  • Device sterilization/disinfection container, reusable

Patient Specific Talus Spacer - 00889795137203

Patient Specific Talus Spacer, Nominal, CoCr
Paragon 28, Inc.
AOPSTSXXXXN
In Commercial Distribution

  • 00889795137203 ()
AOPSTSXXXXN

  • Coated ankle talus prosthesis

Phantom® Fibula Nail System - 00889795137180

1.6mm x 70mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-1670
In Commercial Distribution

  • 00889795137180 ()
P36-913-1670

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795137135

2.0mm x 150mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-2015
In Commercial Distribution

  • 00889795137135 ()
P36-913-2015

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795137111

Removal Hook, Body
Paragon 28, Inc.
P36-970-0006
In Commercial Distribution

  • 00889795137111 ()
P36-970-0006

  • Bone hook

Phantom® Fibula Nail System - 00889795137098

Screw Countersink, AO Quick Connect
Paragon 28, Inc.
P36-911-2735
In Commercial Distribution

  • 00889795137098 ()
P36-911-2735

  • Surgical countersink, single-use

Phantom® Fibula Nail System - 00889795137074

3.2mm R3ACT Drill Bit, 14mm Calibrated, AO Quick Connect
Paragon 28, Inc.
P36-910-3214
In Commercial Distribution

  • 00889795137074 ()
P36-910-3214

  • Fluted surgical drill bit, single-use

Phantom® Fibula Nail System - 00889795137050

6.5mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-6531
In Commercial Distribution

  • 00889795137050 ()
P36-915-6531

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795137043

6.0mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-6031
In Commercial Distribution

  • 00889795137043 ()
P36-915-6031

  • Bone-resection orthopaedic reamer, single-use
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