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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 - 00889795140203

Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 6 - ARC
Paragon 28, Inc.
P11-810-PLA6
In Commercial Distribution

  • 00889795140203 ()
P11-810-PLA6

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795140197

Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 5 - ARC
Paragon 28, Inc.
P11-810-PLA5
In Commercial Distribution

  • 00889795140197 ()
P11-810-PLA5

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795140180

Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 4 - ARC
Paragon 28, Inc.
P11-810-PLA4
In Commercial Distribution

  • 00889795140180 ()
P11-810-PLA4

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795140173

Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 3 - ARC
Paragon 28, Inc.
P11-810-PLA3
In Commercial Distribution

  • 00889795140173 ()
P11-810-PLA3

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795140166

Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 2 - ARC
Paragon 28, Inc.
P11-810-PLA2
In Commercial Distribution

  • 00889795140166 ()
P11-810-PLA2

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795140159

Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 1 - ARC
Paragon 28, Inc.
P11-810-PLA1
In Commercial Distribution

  • 00889795140159 ()
P11-810-PLA1

  • Fixed-bearing total ankle prosthesis

Bun-Yo-Matic™ Lapidus Clamp System - 00889795140142

K-wire Tube, 100mm MAX
Paragon 28, Inc.
P31-941-0100
In Commercial Distribution

  • 00889795140142 ()
P31-941-0100

  • Device sterilization/disinfection container, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795140135

K-wire Tube, 80mm MAX
Paragon 28, Inc.
P31-941-0080
In Commercial Distribution

  • 00889795140135 ()
P31-941-0080

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795137234

Bone Hook, Large Handle
Paragon 28, Inc.
P99-150-1007
In Commercial Distribution

  • 00889795137234 ()
P99-150-1007

  • Bone hook

Patient Specific Talus Spacer - 00889795137210

Patient Specific Talus Spacer, Small, CoCr
Paragon 28, Inc.
AOPSTSXXXXS
In Commercial Distribution

  • 00889795137210 ()
AOPSTSXXXXS

  • Coated ankle talus prosthesis
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