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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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Mini Monster 4.0 X 32mm Headed Screw, Short Thread
Paragon 28, Inc.
P20-140-032S
In Commercial Distribution

  • 00889795003409 ()

  • Outer Diameter: 4 Millimeter
  • Mini Monster 4.0 X 32mm Headed Screw, Short Thread
P20-140-032S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 32mm Headed Screw, Long Thread
Paragon 28, Inc.
P20-140-032L
In Commercial Distribution

  • 00889795003393 ()

  • Mini Monster 4.0 X 32mm Headed Screw, Long Thread
  • Outer Diameter: 4 Millimeter
P20-140-032L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 30mm Headed Screw, Short Thread
Paragon 28, Inc.
P20-140-030S
In Commercial Distribution

  • 00889795003379 ()

  • Outer Diameter: 4 Millimeter
  • Mini Monster 4.0 X 30mm Headed Screw, Short Thread
P20-140-030S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 30mm Headed Screw, Full Thread
Paragon 28, Inc.
P20-140-030F
In Commercial Distribution

  • 00889795003355 ()

  • Mini Monster 4.0 X 30mm Headed Screw, Full Thread
  • Outer Diameter: 4 Millimeter
P20-140-030F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 28mm Headed Screw, Long Thread
Paragon 28, Inc.
P20-140-028L
In Commercial Distribution

  • 00889795003331 ()

  • Mini Monster 4.0 X 28mm Headed Screw, Long Thread
  • Outer Diameter: 4 Millimeter
P20-140-028L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 28mm Headed Screw, Full Thread
Paragon 28, Inc.
P20-140-028F
In Commercial Distribution

  • 00889795003324 ()

  • Mini Monster 4.0 X 28mm Headed Screw, Full Thread
  • Outer Diameter: 4 Millimeter
P20-140-028F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 26mm Headed Screw, Short Thread
Paragon 28, Inc.
P20-140-026S
In Commercial Distribution

  • 00889795003317 ()

  • Outer Diameter: 4 Millimeter
  • Mini Monster 4.0 X 26mm Headed Screw, Short Thread
P20-140-026S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 26mm Headed Screw, Full Thread
Paragon 28, Inc.
P20-140-026F
In Commercial Distribution

  • 00889795003300 ()

  • Outer Diameter: 4 Millimeter
  • Mini Monster 4.0 X 26mm Headed Screw, Full Thread
P20-140-026F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 16MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I216-S
In Commercial Distribution

  • 00889795119285 ()
P10-31A-I216-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 15MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I215-S
In Commercial Distribution

  • 00889795119278 ()
P10-31A-I215-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 14MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I214-S
In Commercial Distribution

  • 00889795119261 ()
P10-31A-I214-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 13MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I213-S
In Commercial Distribution

  • 00889795119254 ()
P10-31A-I213-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 12MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I212-S
In Commercial Distribution

  • 00889795119247 ()
P10-31A-I212-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 11MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I211-S
In Commercial Distribution

  • 00889795119230 ()
P10-31A-I211-S

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

  • 00889795119223 ()
P10-31P-I120-S

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

  • 00889795119216 ()
P10-31P-I119-S

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

  • 00889795119209 ()
P10-31P-I118-S

  • Fixed-bearing total ankle prosthesis
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
Spherical Washer (Pair) TOP
Paragon 28, Inc.
P45-944-0001
In Commercial Distribution

  • 00889795118981 ()
P45-944-0001

  • External orthopaedic fixation system, single-use
Rancho Cube, Ø6.0 Centering Collar
Paragon 28, Inc.
P45-925-0106
In Commercial Distribution

  • 00889795118974 ()
P45-925-0106

  • External orthopaedic fixation system, single-use
Wire Bolt, Offset & Center hole
Paragon 28, Inc.
P45-913-2001
In Commercial Distribution

  • 00889795118967 ()
P45-913-2001

  • External orthopaedic fixation system, single-use
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