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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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Monster Screw System - 00889795012999

Mini-Monster, Screw, Ø3.5 x 22mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-435-022S
In Commercial Distribution

  • 00889795012999 ()

  • Mini-Monster, Screw, Ø3.5 x 22mm, Headed, Short Thd, Solid, Blunt Tip, TiA
  • Outer Diameter: 3.5 Millimeter
P20-435-022S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012982

Mini-Monster, Screw, Ø3.5 x 20mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-435-020S
In Commercial Distribution

  • 00889795012982 ()

  • Mini-Monster, Screw, Ø3.5 x 20mm, Headed, Short Thd, Solid, Blunt Tip, TiA
  • Outer Diameter: 3.5 Millimeter
P20-435-020S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012975

Mini-Monster, Screw, Ø3.5 x 18mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-435-018S
In Commercial Distribution

  • 00889795012975 ()

  • Outer Diameter: 3.5 Millimeter
  • Mini-Monster, Screw, Ø3.5 x 18mm, Headed, Short Thd, Solid, Blunt Tip, TiA
P20-435-018S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012968

Mini-Monster, Screw, Ø3.5 x 16mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-435-016S
In Commercial Distribution

  • 00889795012968 ()

  • Outer Diameter: 3.5 Millimeter
  • Mini-Monster, Screw, Ø3.5 x 16mm, Headed, Short Thd, Solid, Blunt Tip, TiA
P20-435-016S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012951

Mini-Monster, Screw, Ø3.5 x 14mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-435-014S
In Commercial Distribution

  • 00889795012951 ()

  • Outer Diameter: 3.5 Millimeter
  • Mini-Monster, Screw, Ø3.5 x 14mm, Headed, Short Thd, Solid, Blunt Tip, TiA
P20-435-014S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012944

Mini-Monster, Screw, Ø3.5 x 12mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-435-012S
In Commercial Distribution

  • 00889795012944 ()

  • Mini-Monster, Screw, Ø3.5 x 12mm, Headed, Short Thd, Solid, Blunt Tip, TiA
  • Outer Diameter: 3.5 Millimeter
P20-435-012S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012937

Mini-Monster, Screw, Ø3.5 x 10mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-435-010S
In Commercial Distribution

  • 00889795012937 ()

  • Outer Diameter: 3.5 Millimeter
  • Mini-Monster, Screw, Ø3.5 x 10mm, Headed, Short Thd, Solid, Blunt Tip, TiA
P20-435-010S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012777

Mini-Monster, Screw, Ø2.7 x 40mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-427-040S
In Commercial Distribution

  • 00889795012777 ()

  • Outer Diameter: 2.7 Millimeter
  • Mini-Monster, Screw, Ø2.7 x 40mm, Headed, Short Thd, Solid, Blunt Tip, TiA
P20-427-040S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012760

Mini-Monster, Screw, Ø2.7 x 38mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-427-038S
In Commercial Distribution

  • 00889795012760 ()

  • Mini-Monster, Screw, Ø2.7 x 38mm, Headed, Short Thd, Solid, Blunt Tip, TiA
  • Outer Diameter: 2.7 Millimeter
P20-427-038S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012753

Mini-Monster, Screw, Ø2.7 x 36mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-427-036S
In Commercial Distribution

  • 00889795012753 ()

  • Mini-Monster, Screw, Ø2.7 x 36mm, Headed, Short Thd, Solid, Blunt Tip, TiA
  • Outer Diameter: 2.7 Millimeter
P20-427-036S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012739

Mini-Monster, Screw, Ø2.7 x 32mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-427-032S
In Commercial Distribution

  • 00889795012739 ()

  • Mini-Monster, Screw, Ø2.7 x 32mm, Headed, Short Thd, Solid, Blunt Tip, TiA
  • Outer Diameter: 2.7 Millimeter
P20-427-032S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012715

Mini-Monster, Screw, Ø2.7 x 28mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-427-028S
In Commercial Distribution

  • 00889795012715 ()

  • Outer Diameter: 2.7 Millimeter
  • Mini-Monster, Screw, Ø2.7 x 28mm, Headed, Short Thd, Solid, Blunt Tip, TiA
P20-427-028S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Monster Screw System - 00889795012708

Mini-Monster, Screw, Ø2.7 x 26mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P20-427-026S
In Commercial Distribution

  • 00889795012708 ()

  • Mini-Monster, Screw, Ø2.7 x 26mm, Headed, Short Thd, Solid, Blunt Tip, TiA
  • Outer Diameter: 2.7 Millimeter
P20-427-026S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

APEX 3D Total Ankle Replacement System - 00889795011893

Total Ankle, Instrument, Poly Trial Insert, Size 2, 15MM, 3.25MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I215
In Commercial Distribution

  • 00889795011893 ()
P10-931-I215

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011886

Total Ankle, Instrument, Poly Trial Insert, Size 2, 14MM, 3.25MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I214
In Commercial Distribution

  • 00889795011886 ()
P10-931-I214

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011879

Total Ankle, Instrument, Poly Trial Insert, Size 2, 13MM, 3.25MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I213
In Commercial Distribution

  • 00889795011879 ()
P10-931-I213

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011862

Total Ankle, Instrument, Poly Trial Insert, Size 2, 12MM, 3.25MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I212
In Commercial Distribution

  • 00889795011862 ()
P10-931-I212

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011855

Total Ankle, Instrument, Poly Trial Insert, Size 2, 11MM, 3.25MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I211
In Commercial Distribution

  • 00889795011855 ()
P10-931-I211

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011848

Total Ankle, Instrument, Poly Trial Insert, Size 1, 20MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I120
In Commercial Distribution

  • 00889795011848 ()
P10-931-I120

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011831

Total Ankle, Instrument, Poly Trial Insert, Size 1, 19MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I119
In Commercial Distribution

  • 00889795011831 ()
P10-931-I119

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011824

Total Ankle, Instrument, Poly Trial Insert, Size 1, 18MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I118
In Commercial Distribution

  • 00889795011824 ()
P10-931-I118

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011817

Total Ankle, Instrument, Poly Trial Insert, Size 1, 17MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I117
In Commercial Distribution

  • 00889795011817 ()
P10-931-I117

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011800

Total Ankle, Instrument, Poly Trial Insert, Size 1, 16MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I116
In Commercial Distribution

  • 00889795011800 ()
P10-931-I116

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011794

Total Ankle, Instrument, Poly Trial Insert, Size 1, 15MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I115
In Commercial Distribution

  • 00889795011794 ()
P10-931-I115

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011787

Total Ankle, Instrument, Poly Trial Insert, Size 1, 14MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I114
In Commercial Distribution

  • 00889795011787 ()
P10-931-I114

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011770

Total Ankle, Instrument, Poly Trial Insert, Size 1, 13MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I113
In Commercial Distribution

  • 00889795011770 ()
P10-931-I113

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011763

Total Ankle, Instrument, Poly Trial Insert, Size 1, 12MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I112
In Commercial Distribution

  • 00889795011763 ()
P10-931-I112

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795011756

Total Ankle, Instrument, Poly Trial Insert, Size 1, 11MM, 3.00MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I111
In Commercial Distribution

  • 00889795011756 ()
P10-931-I111

  • Surgical implant template, reusable

Monkey Rings™ External Fixation System - 00889795011749

Modular Quick Adjust Strut, Short
Paragon 28, Inc.
P45-224-0130
In Commercial Distribution

  • 00889795011749 ()
P45-224-0130

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795011732

Modular Quick Adjust Strut, Medium
Paragon 28, Inc.
P45-224-0170
In Commercial Distribution

  • 00889795011732 ()
P45-224-0170

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795011725

Modular Quick Adjust Strut, Large
Paragon 28, Inc.
P45-224-0250
In Commercial Distribution

  • 00889795011725 ()
P45-224-0250

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795011718

Monkey Rings™ Tray 2, Case 2 of 4
Paragon 28, Inc.
P45-902-TRY2
In Commercial Distribution

  • 00889795011718 ()
P45-902-TRY2

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795011701

Monkey Rings™ Tray 1, Case 2 of 4
Paragon 28, Inc.
P45-902-TRY1
In Commercial Distribution

  • 00889795011701 ()
P45-902-TRY1

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795011640

Total Ankle, Instrument, Alignment Guide, JL/I-E Pointer, Gen II, SS
Paragon 28, Inc.
P10-841-AL07
In Commercial Distribution

  • 00889795011640 ()
P10-841-AL07

  • Orthopaedic fixation implant alignment tool

APEX 3D Total Ankle Replacement System - 00889795011633

4BAR Distractor, Gen II
Paragon 28, Inc.
P10-851-4BAR
In Commercial Distribution

  • 00889795011633 ()
P10-851-4BAR

  • Orthopaedic surgical distractor, internal

APEX 3D Total Ankle Replacement System - 00889795011626

Tibia Impaction Handle, GenII
Paragon 28, Inc.
P10-851-TB00
In Commercial Distribution

  • 00889795011626 ()
P10-851-TB00

  • Surgical instrument handle, torque-limiting

APEX 3D Total Ankle Replacement System - 00889795011619

APEX 3D Total Ankle, Instrument, Alignment Wing, GEN II
Paragon 28, Inc.
P10-841-AW01
In Commercial Distribution

  • 00889795011619 ()
P10-841-AW01

  • Orthopaedic fixation implant alignment tool

Gorilla Plating System - 00889795011602

4.2 x 70 mm Non-Locking Plate Screw
Paragon 28, Inc.
P50-153-4270
In Commercial Distribution

  • 00889795011602 ()

  • Outer Diameter: 4.2 Millimeter
  • 4.2 x 70 mm Non-Locking Plate Screw
P50-153-4270

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Gorilla Plating System - 00889795011572

4.2 x 65 mm Non-Locking Plate Screw
Paragon 28, Inc.
P50-153-4265
In Commercial Distribution

  • 00889795011572 ()

  • Outer Diameter: 4.2 Millimeter
  • 4.2 x 65 mm Non-Locking Plate Screw
P50-153-4265

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Gorilla Plating System - 00889795011541

4.2 x 60 mm Non-Locking Plate Screw
Paragon 28, Inc.
P50-153-4260
In Commercial Distribution

  • 00889795011541 ()

  • Outer Diameter: 4.2 Millimeter
  • 4.2 x 60 mm Non-Locking Plate Screw
P50-153-4260

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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