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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 - 00889795137531

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Right, Size 4, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR4S-S
In Commercial Distribution

  • 00889795137531 ()
P11-180-BR4S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137500

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Right, Size 3, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR3S-S
In Commercial Distribution

  • 00889795137500 ()
P11-180-BR3S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137487

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Right, Size 2, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR2L-S
In Commercial Distribution

  • 00889795137487 ()
P11-180-BR2L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137470

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Right, Size 2, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR2S-S
In Commercial Distribution

  • 00889795137470 ()
P11-180-BR2S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137449

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Right, Size 1, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR1S-S
In Commercial Distribution

  • 00889795137449 ()
P11-180-BR1S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137425

Short Stem Tibia, ARC, Short Stem (12X12MM Lattice), Left, Size 6, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL6L-S
In Commercial Distribution

  • 00889795137425 ()
P11-180-BL6L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137357

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Left, Size 4, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL4S-S
In Commercial Distribution

  • 00889795137357 ()
P11-180-BL4S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137326

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Left, Size 3, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL3S-S
In Commercial Distribution

  • 00889795137326 ()
P11-180-BL3S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137296

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 2, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL2S-S
In Commercial Distribution

  • 00889795137296 ()
P11-180-BL2S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137272

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 1, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL1L-S
In Commercial Distribution

  • 00889795137272 ()
P11-180-BL1L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137265

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 1, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL1S-S
In Commercial Distribution

  • 00889795137265 ()
P11-180-BL1S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137258

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 1, Short, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL10-S
In Commercial Distribution

  • 00889795137258 ()
P11-180-BL10-S

  • Fixed-bearing total ankle prosthesis

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

Patient Specific Talus Spacer - 00889795137203

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

  • 00889795137203 ()
AOPSTSXXXXN

  • Coated ankle talus prosthesis

Patient Specific Talus Spacer - 00889795137197

Patient Specific Talus Spacer, Large, CoCr
Paragon 28, Inc.
AOPSTSXXXXL
In Commercial Distribution

  • 00889795137197 ()
AOPSTSXXXXL

  • 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 - 00889795137081

3.2mm R3ACT Drill Bit, 17mm Calibrated, AO Quick Connect
Paragon 28, Inc.
P36-910-3217
In Commercial Distribution

  • 00889795137081 ()
P36-910-3217

  • Fluted surgical drill bit, single-use
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