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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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Monkey Bars™ Pin to Bar External Fixation System - 00889795145611

Half Pin, 4 x 20mm, Self-Tapping
Paragon 28, Inc.
P47-210-420S
In Commercial Distribution

  • 00889795145611 ()
P47-210-420S

  • External orthopaedic fixation system, single-use

Monkey Bars™ Pin to Bar External Fixation System - 00889795145604

Half Pin, 3 x 20mm, Blunt-Tipped
Paragon 28, Inc.
P47-210-320B
In Commercial Distribution

  • 00889795145604 ()
P47-210-320B

  • External orthopaedic fixation system, single-use

Monkey Bars™ Pin to Bar External Fixation System - 00889795145598

Half Pin, 3 x 20mm, Self-Tapping
Paragon 28, Inc.
P47-210-320S
In Commercial Distribution

  • 00889795145598 ()
P47-210-320S

  • External orthopaedic fixation system, single-use

Baby Gorilla® / Gorilla® Plating System - 00889795145574

Gorilla®, R3CON™ Screw, Ø2.7 x 80mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2780
In Commercial Distribution

  • 00889795145574 ()
P50-453-2780

  • Orthopaedic bone screw (non-sliding)

Baby Gorilla® / Gorilla® Plating System - 00889795145567

Gorilla®, R3CON™ Screw, Ø2.7 x 75mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2775
In Commercial Distribution

  • 00889795145567 ()
P50-453-2775

  • Orthopaedic bone screw (non-sliding)

Baby Gorilla® / Gorilla® Plating System - 00889795145550

Gorilla®, R3CON™ Screw, Ø2.7 x 70mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2770
In Commercial Distribution

  • 00889795145550 ()
P50-453-2770

  • Orthopaedic bone screw (non-sliding)

Baby Gorilla® / Gorilla® Plating System - 00889795145543

Gorilla®, R3CON™ Screw, Ø2.7 x 68mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2768
In Commercial Distribution

  • 00889795145543 ()
P50-453-2768

  • Orthopaedic bone screw (non-sliding)

Baby Gorilla® / Gorilla® Plating System - 00889795145536

Gorilla®, R3CON™ Screw, Ø2.7 x 66mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2766
In Commercial Distribution

  • 00889795145536 ()
P50-453-2766

  • Orthopaedic bone screw (non-sliding)

Baby Gorilla® / Gorilla® Plating System - 00889795145529

Gorilla®, R3CON™ Screw, Ø2.7 x 65mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2765
In Commercial Distribution

  • 00889795145529 ()
P50-453-2765

  • Orthopaedic bone screw (non-sliding)

Baby Gorilla® / Gorilla® Plating System - 00889795145512

Gorilla®, R3CON™ Screw, Ø2.7 x 64mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2764
In Commercial Distribution

  • 00889795145512 ()
P50-453-2764

  • Orthopaedic bone screw (non-sliding)

Baby Gorilla® / Gorilla® Plating System - 00889795145505

Gorilla®, R3CON™ Screw, Ø2.7 x 62mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2762
In Commercial Distribution

  • 00889795145505 ()
P50-453-2762

  • Orthopaedic bone screw (non-sliding)

Baby Gorilla/Gorilla Plating System - 00889795145499

Drill Guide Sleeve, 4.2mm, R3CON
Paragon 28, Inc.
P51-913-2842-03
In Commercial Distribution

  • 00889795145499 ()
P51-913-2842-03

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795145482

Ovr Dr Gd, Dbl End, 2.8/4.2mm, R3CON
Paragon 28, Inc.
P51-913-2842
In Commercial Distribution

  • 00889795145482 ()
P51-913-2842

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795145475

Drl Gd Slv, 3.5mm, R3CON
Paragon 28, Inc.
P51-913-2435-03
In Commercial Distribution

  • 00889795145475 ()
P51-913-2435-03

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795145468

Ovr Dr Gd, Dbl End, 2.4/3.5mm, R3CON
Paragon 28, Inc.
P51-913-2435
In Commercial Distribution

  • 00889795145468 ()
P51-913-2435

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795145444

Ovr Dr Gd, Dbl End, 2.0/2.7mm, R3CON
Paragon 28, Inc.
P51-913-2027
In Commercial Distribution

  • 00889795145444 ()
P51-913-2027

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795143938

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 20 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I520-S
In Commercial Distribution

  • 00889795143938 ()
P10-310-I520-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143921

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 18 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I518-S
In Commercial Distribution

  • 00889795143921 ()
P10-310-I518-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143914

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 16 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I516-S
In Commercial Distribution

  • 00889795143914 ()
P10-310-I516-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143907

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 14 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I514-S
In Commercial Distribution

  • 00889795143907 ()
P10-310-I514-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143891

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 12 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I512-S
In Commercial Distribution

  • 00889795143891 ()
P10-310-I512-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143884

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 11 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I511-S
In Commercial Distribution

  • 00889795143884 ()
P10-310-I511-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143853

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 8 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I508-S
In Commercial Distribution

  • 00889795143853 ()
P10-310-I508-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143839

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 6 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I506-S
In Commercial Distribution

  • 00889795143839 ()
P10-310-I506-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143778

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 11 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I411-S
In Commercial Distribution

  • 00889795143778 ()
P10-310-I411-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143754

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 9 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I409-S
In Commercial Distribution

  • 00889795143754 ()
P10-310-I409-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143747

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 8 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I408-S
In Commercial Distribution

  • 00889795143747 ()
P10-310-I408-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143730

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 7 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I407-S
In Commercial Distribution

  • 00889795143730 ()
P10-310-I407-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143723

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 6 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I406-S
In Commercial Distribution

  • 00889795143723 ()
P10-310-I406-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143716

TOTAL ANKLE IMPLANT, INSERT, SIZE 3, 20 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I320-S
In Commercial Distribution

  • 00889795143716 ()
P10-310-I320-S

  • Fixed-bearing total ankle prosthesis
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