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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 Total Ankle Replacement System - 00889795117441

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 10MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I110-S
In Commercial Distribution

  • 00889795117441 ()
P10-31A-I110-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117434

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 9MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I109-S
In Commercial Distribution

  • 00889795117434 ()
P10-31A-I109-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117427

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 8MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I108-S
In Commercial Distribution

  • 00889795117427 ()
P10-31A-I108-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117410

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 7MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I107-S
In Commercial Distribution

  • 00889795117410 ()
P10-31A-I107-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117403

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 6MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I106-S
In Commercial Distribution

  • 00889795117403 ()
P10-31A-I106-S

  • Fixed-bearing total ankle prosthesis

Monkey Rings™ External Fixation System - 00889795116574

Monkey Rings, Case 4, Tray 2
Paragon 28, Inc.
P45-904-TRY2
In Commercial Distribution

  • 00889795116574 ()
P45-904-TRY2

  • Device sterilization/disinfection container, reusable

Monkey Rings External Fixation System - 00889795116468

Ratchet Wrench, 10mm (OIC wrench)
Paragon 28, Inc.
P45-513-0010
In Commercial Distribution

  • 00889795116468 ()
P45-513-0010

  • Surgical torque wrench, reusable

Monkey Rings™ External Fixation System - 00889795116215

Female Post, 1 Hole
Paragon 28, Inc.
P45-920-0001
In Commercial Distribution

  • 00889795116215 ()
P45-920-0001

  • External orthopaedic fixation system, single-use

Monkey Rings External Fixation System - 00889795115287

Wire, Ø2.0 x 400 Reduction, Half Point
Paragon 28, Inc.
P45-195-2040
In Commercial Distribution

  • 00889795115287 ()
P45-195-2040

  • Orthopaedic bone wire

Monkey Rings External Fixation System - 00889795115263

Wire, Ø2.0 x 400 Smooth, Half Point
Paragon 28, Inc.
P45-194-2040
In Commercial Distribution

  • 00889795115263 ()
P45-194-2040

  • Orthopaedic bone wire
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