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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 - 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 - 00889795076359

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 14MM, NEUTRAL
Paragon 28, Inc.
P10-310-I514-S
In Commercial Distribution

  • 00889795076359 ()
P10-310-I514-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795076335

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 12MM, NEUTRAL
Paragon 28, Inc.
P10-310-I512-S
In Commercial Distribution

  • 00889795076335 ()
P10-310-I512-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 - 00889795076298

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 8MM, NEUTRAL
Paragon 28, Inc.
P10-310-I508-S
In Commercial Distribution

  • 00889795076298 ()
P10-310-I508-S

  • Fixed-bearing total ankle prosthesis

Precision MIS Bunion System - 00889795131942

Precision MIS Screw, Cannulated, Ø3.5 x 70mm
Paragon 28, Inc.
P27-135-0070
In Commercial Distribution

  • 00889795131942 ()
P27-135-0070

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131935

Precision MIS Screw, Cannulated, Ø3.5 x 68mm
Paragon 28, Inc.
P27-135-0068
In Commercial Distribution

  • 00889795131935 ()
P27-135-0068

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131928

Precision MIS Screw, Cannulated, Ø3.5 x 66mm
Paragon 28, Inc.
P27-135-0066
In Commercial Distribution

  • 00889795131928 ()
P27-135-0066

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131911

Precision MIS Screw, Cannulated, Ø3.5 x 64mm
Paragon 28, Inc.
P27-135-0064
In Commercial Distribution

  • 00889795131911 ()
P27-135-0064

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131904

Precision MIS Screw, Cannulated, Ø3.5 x 62mm
Paragon 28, Inc.
P27-135-0062
In Commercial Distribution

  • 00889795131904 ()
P27-135-0062

  • Orthopaedic bone screw (non-sliding)
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