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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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Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 1, Thickness 9mm
OPTIMOTION IMPLANTS LLC
1014-P-1109
In Commercial Distribution

  • B6961014P11090 ()


  • Cruciate-retaining total knee prosthesis
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™ 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™ 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™ 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™ Cross-linked Vitamin E POLY, SIZE 5 x 9MM, NEUTRAL
Paragon 28, Inc.
P10-310-I509-S
In Commercial Distribution

  • 00889795076304 ()
P10-310-I509-S

  • Fixed-bearing total ankle prosthesis
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
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™ 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™ Cross-linked Vitamin E POLY, SIZE 4 x 20MM, NEUTRAL
Paragon 28, Inc.
P10-310-I420-S
In Commercial Distribution

  • 00889795075062 ()
P10-310-I420-S

  • Fixed-bearing total ankle prosthesis
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