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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 - 00889795110961

HEX SCREW DRIVER, SHORT, 3.5mm X 155mm
Paragon 28, Inc.
P99-150-HX35-SHORT
In Commercial Distribution

  • 00889795110961 ()
P99-150-HX35-SHORT

  • Surgical screwdriver, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110954

Screw Retention Sleeve
Paragon 28, Inc.
P99-191-SL10
In Commercial Distribution

  • 00889795110954 ()
P99-191-SL10

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110930

Ø3.5 x 13cm Solid Over Drill
Paragon 28, Inc.
P99-100-3513
In Commercial Distribution

  • 00889795110930 ()
P99-100-3513

  • Cannulated surgical drill bit, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110916

Ø4.2 Gorilla Tap
Paragon 28, Inc.
P51-911-4200
In Commercial Distribution

  • 00889795110916 ()
P51-911-4200

  • Bone tap, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110909

Ø3.5 Gorilla Tap
Paragon 28, Inc.
P51-911-3500
In Commercial Distribution

  • 00889795110909 ()
P51-911-3500

  • Bone tap, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110893

Ø2.7 Gorilla Tap
Paragon 28, Inc.
P51-911-2700
In Commercial Distribution

  • 00889795110893 ()
P51-911-2700

  • Bone tap, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795110824

Proximal Arm Assembly
Paragon 28, Inc.
P31-950-0035
In Commercial Distribution

  • 00889795110824 ()
P31-950-0035

  • Orthopaedic implantation sleeve, reusable

APEX 3D Total Ankle Replacement System - 00889795110572

Total Ankle Replacement System, Poly Trial Insert, Size 3, 16mm
Paragon 28, Inc.
P10-930-I316
In Commercial Distribution

  • 00889795110572 ()
P10-930-I316

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110565

Total Ankle Replacement System, Poly Trial Insert, Size 3, 14mm
Paragon 28, Inc.
P10-930-I314
In Commercial Distribution

  • 00889795110565 ()
P10-930-I314

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795076397

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 18MM, NEUTRAL
Paragon 28, Inc.
P10-310-I518-S
In Commercial Distribution

  • 00889795076397 ()
P10-310-I518-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076328

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 11MM, NEUTRAL
Paragon 28, Inc.
P10-310-I511-S
In Commercial Distribution

  • 00889795076328 ()
P10-310-I511-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076311

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 10MM, NEUTRAL
Paragon 28, Inc.
P10-310-I510-S
In Commercial Distribution

  • 00889795076311 ()
P10-310-I510-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076281

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 7MM, NEUTRAL
Paragon 28, Inc.
P10-310-I507-S
In Commercial Distribution

  • 00889795076281 ()
P10-310-I507-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076274

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 6MM, NEUTRAL
Paragon 28, Inc.
P10-310-I506-S
In Commercial Distribution

  • 00889795076274 ()
P10-310-I506-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795075048

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 18MM, NEUTRAL
Paragon 28, Inc.
P10-310-I418-S
In Commercial Distribution

  • 00889795075048 ()
P10-310-I418-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795075024

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 16MM, NEUTRAL
Paragon 28, Inc.
P10-310-I416-S
In Commercial Distribution

  • 00889795075024 ()
P10-310-I416-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795075000

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 14MM, NEUTRAL
Paragon 28, Inc.
P10-310-I414-S
In Commercial Distribution

  • 00889795075000 ()
P10-310-I414-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795074980

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 12MM, NEUTRAL
Paragon 28, Inc.
P10-310-I412-S
In Commercial Distribution

  • 00889795074980 ()
P10-310-I412-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795074973

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 11MM, NEUTRAL
Paragon 28, Inc.
P10-310-I411-S
In Commercial Distribution

  • 00889795074973 ()
P10-310-I411-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795074966

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 10MM, NEUTRAL
Paragon 28, Inc.
P10-310-I410-S
In Commercial Distribution

  • 00889795074966 ()
P10-310-I410-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795074959

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 9MM, NEUTRAL
Paragon 28, Inc.
P10-310-I409-S
In Commercial Distribution

  • 00889795074959 ()
P10-310-I409-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795074942

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 8MM, NEUTRAL
Paragon 28, Inc.
P10-310-I408-S
In Commercial Distribution

  • 00889795074942 ()
P10-310-I408-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795074935

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 7MM, NEUTRAL
Paragon 28, Inc.
P10-310-I407-S
In Commercial Distribution

  • 00889795074935 ()
P10-310-I407-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795074928

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 6MM, NEUTRAL
Paragon 28, Inc.
P10-310-I406-S
In Commercial Distribution

  • 00889795074928 ()
P10-310-I406-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795073716

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 20MM, NEUTRAL
Paragon 28, Inc.
P10-310-I320-S
In Commercial Distribution

  • 00889795073716 ()
P10-310-I320-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795073693

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 18MM, NEUTRAL
Paragon 28, Inc.
P10-310-I318-S
In Commercial Distribution

  • 00889795073693 ()
P10-310-I318-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795073679

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 16MM, NEUTRAL
Paragon 28, Inc.
P10-310-I316-S
In Commercial Distribution

  • 00889795073679 ()
P10-310-I316-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795073655

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 14MM, NEUTRAL
Paragon 28, Inc.
P10-310-I314-S
In Commercial Distribution

  • 00889795073655 ()
P10-310-I314-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795073631

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 12MM, NEUTRAL
Paragon 28, Inc.
P10-310-I312-S
In Commercial Distribution

  • 00889795073631 ()
P10-310-I312-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795073624

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 11MM, NEUTRAL
Paragon 28, Inc.
P10-310-I311-S
In Commercial Distribution

  • 00889795073624 ()
P10-310-I311-S

  • Fixed-bearing total ankle prosthesis
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