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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 - 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 S Total Ankle Replacement System - 00889795140661

Apex 3D-S TAR X-ray Templates Packet
Paragon 28, Inc.
P11-900-TEMP
In Commercial Distribution

  • 00889795140661 ()
P11-900-TEMP

  • Surgical implant template, 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 - 00889795140647

Short Stem Tibia, Instrument, Drill Wrench
Paragon 28, Inc.
P11-854-WR01
In Commercial Distribution

  • 00889795140647 ()
P11-854-WR01

  • Surgical torque wrench, reusable

APEX 3D Total Ankle Replacement System - 00889795140630

Right Angle Drill - Hex Socket Driver
Paragon 28, Inc.
P11-854-RAD1-17
In Commercial Distribution

  • 00889795140630 ()
P11-854-RAD1-17

  • Surgical screwdriver, reusable

APEX 3D S Total Ankle Replacement System - 00889795140616

Short Stem Tibia, Instrument, Right Angle Drill
Paragon 28, Inc.
P11-854-RAD1
In Commercial Distribution

  • 00889795140616 ()
P11-854-RAD1

  • Fluted surgical drill bit, reusable

APEX 3D S Total Ankle Replacement System - 00889795140609

Short Stem Tibia, Instrument, Manual Drill
Paragon 28, Inc.
P11-854-MD01
In Commercial Distribution

  • 00889795140609 ()
P11-854-MD01

  • Fluted surgical drill bit, reusable

APEX 3D S Total Ankle Replacement System - 00889795140593

Short Stem Tibia, Instrument, Linear Guide Rail
Paragon 28, Inc.
P11-854-LG10
In Commercial Distribution

  • 00889795140593 ()
P11-854-LG10

  • Osteotomy guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140586

Short Stem Tibia, Instrument, Drill Bit, Tall, D12 x H14
Paragon 28, Inc.
P11-854-D12T
In Commercial Distribution

  • 00889795140586 ()
P11-854-D12T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795140579

Short Stem Tibia, Instrument, Drill Bit, Pilot, D12 x H7.5
Paragon 28, Inc.
P11-854-D12S
In Commercial Distribution

  • 00889795140579 ()
P11-854-D12S

  • Cannulated surgical drill bit, single-use
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