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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 - 00889795137388

Short Stem Tibia, ARC, Short Stem (12X12MM Lattice), Left, Size 5, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL5S-S
In Commercial Distribution

  • 00889795137388 ()
P11-180-BL5S-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 - 00889795137333

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Left, Size 3, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL3L-S
In Commercial Distribution

  • 00889795137333 ()
P11-180-BL3L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137302

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 2, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL2L-S
In Commercial Distribution

  • 00889795137302 ()
P11-180-BL2L-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 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

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 - 00889795137203

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

  • 00889795137203 ()
AOPSTSXXXXN

  • Coated ankle talus prosthesis

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 - 00889795137104

4.0mm Single Lead Tap, AO Quick Connect
Paragon 28, Inc.
P36-921-4018
In Commercial Distribution

  • 00889795137104 ()
P36-921-4018

  • Bone tap, single-use
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