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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 - 00889795140555

Short Stem Tibia, Instrument, Drill Bit, Pilot, D10.5 x H7.5
Paragon 28, Inc.
P11-854-D10S
In Commercial Distribution

  • 00889795140555 ()
P11-854-D10S

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795140548

Short Stem Tibia, Instrument, Drill Bit, Tall, D9 x H14
Paragon 28, Inc.
P11-854-D09T
In Commercial Distribution

  • 00889795140548 ()
P11-854-D09T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795140531

Short Stem Tibia, Instrument, Impaction Protector (Size 5+6)
Paragon 28, Inc.
P11-851-TP56
In Commercial Distribution

  • 00889795140531 ()
P11-851-TP56

  • Orthopaedic implant impactor, single-use

APEX 3D S Total Ankle Replacement System - 00889795140524

Short Stem Tibia, Instrument, Impaction Protector (Size 3+4)
Paragon 28, Inc.
P11-851-TP34
In Commercial Distribution

  • 00889795140524 ()
P11-851-TP34

  • Orthopaedic implant impactor, single-use

APEX 3D S Total Ankle Replacement System - 00889795140517

Short Stem Tibia, Instrument, Impaction Protector (Size 1+2)
Paragon 28, Inc.
P11-851-TP12
In Commercial Distribution

  • 00889795140517 ()
P11-851-TP12

  • Orthopaedic implant impactor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795140500

Explant Hook 2.0
Paragon 28, Inc.
P31-958-0006
In Commercial Distribution

  • 00889795140500 ()
P31-958-0006

  • Orthopaedic inorganic implant inserter/extractor, single-use

APEX 3D S Total Ankle Replacement System - 00889795140494

Short Stem Tibia, Instrument, Forked Paddle, Flat
Paragon 28, Inc.
P11-851-P041
In Commercial Distribution

  • 00889795140494 ()
P11-851-P041

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D S Total Ankle Replacement System - 00889795140487

Short Stem Tibia, Instrument, Flat Paddle - 2
Paragon 28, Inc.
P11-851-P032
In Commercial Distribution

  • 00889795140487 ()
P11-851-P032

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D S Total Ankle Replacement System - 00889795140463

Short Stem Tibia, Instrument, Implantation Paddle
Paragon 28, Inc.
P11-851-P021
In Commercial Distribution

  • 00889795140463 ()
P11-851-P021

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D S Total Ankle Replacement System - 00889795140456

Short Stem Tibia, Instrument, Forked Paddle, Arc
Paragon 28, Inc.
P11-851-P051
In Commercial Distribution

  • 00889795140456 ()
P11-851-P051

  • Surgical implant/trial-implant/sizer holder, reusable
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