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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™ Cross-linked Vitamin E POLY, SIZE 1 x 17MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I117-S
In Commercial Distribution

  • 00889795119193 ()
P10-31P-I117-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 16MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I116-S
In Commercial Distribution

  • 00889795119186 ()
P10-31P-I116-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 15MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I115-S
In Commercial Distribution

  • 00889795119179 ()
P10-31P-I115-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 14MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I114-S
In Commercial Distribution

  • 00889795119162 ()
P10-31P-I114-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 13MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I113-S
In Commercial Distribution

  • 00889795119155 ()
P10-31P-I113-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 12MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I112-S
In Commercial Distribution

  • 00889795119148 ()
P10-31P-I112-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 11MM, 3MM POST OFFSET
Paragon 28, Inc.
P10-31P-I111-S
In Commercial Distribution

  • 00889795119131 ()
P10-31P-I111-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 20MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I120-S
In Commercial Distribution

  • 00889795119124 ()
P10-31A-I120-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 19MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I119-S
In Commercial Distribution

  • 00889795119117 ()
P10-31A-I119-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 18MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I118-S
In Commercial Distribution

  • 00889795119100 ()
P10-31A-I118-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 16MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I116-S
In Commercial Distribution

  • 00889795119087 ()
P10-31A-I116-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 15MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I115-S
In Commercial Distribution

  • 00889795119070 ()
P10-31A-I115-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 14MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I114-S
In Commercial Distribution

  • 00889795119063 ()
P10-31A-I114-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 13MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I113-S
In Commercial Distribution

  • 00889795119056 ()
P10-31A-I113-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 12MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I112-S
In Commercial Distribution

  • 00889795119049 ()
P10-31A-I112-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 11MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I111-S
In Commercial Distribution

  • 00889795119032 ()
P10-31A-I111-S

  • Fixed-bearing total ankle prosthesis
5.5mm cannulated tap, chronic anchor
Paragon 28, Inc.
P44-960-1055-S
In Commercial Distribution

  • 00889795119025 ()
P44-960-1055-S

  • Bone tap, single-use
4.5mm cannulated tap, chronic anchor
Paragon 28, Inc.
P44-960-1045-S
In Commercial Distribution

  • 00889795119018 ()
P44-960-1045-S

  • Bone tap, single-use
Total Ankle Replacement System, Offset Poly Trial Case
Paragon 28, Inc.
P10-900-APTR
In Commercial Distribution

  • 00889795119001 ()
P10-900-APTR

  • Device sterilization/disinfection container, reusable
Spherical Washer (Pair) Bottom
Paragon 28, Inc.
P45-944-0002
In Commercial Distribution

  • 00889795118998 ()
P45-944-0002

  • External orthopaedic fixation system, single-use
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