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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 - 00889795070951

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 14MM, NEUTRAL
Paragon 28, Inc.
P10-310-I114-S
In Commercial Distribution

  • 00889795070951 ()
P10-310-I114-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070937

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 12MM, NEUTRAL
Paragon 28, Inc.
P10-310-I112-S
In Commercial Distribution

  • 00889795070937 ()
P10-310-I112-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070920

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 11MM, NEUTRAL
Paragon 28, Inc.
P10-310-I111-S
In Commercial Distribution

  • 00889795070920 ()
P10-310-I111-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070913

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 10MM, NEUTRAL
Paragon 28, Inc.
P10-310-I110-S
In Commercial Distribution

  • 00889795070913 ()
P10-310-I110-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070906

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 9MM, NEUTRAL
Paragon 28, Inc.
P10-310-I109-S
In Commercial Distribution

  • 00889795070906 ()
P10-310-I109-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070883

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 7MM, NEUTRAL
Paragon 28, Inc.
P10-310-I107-S
In Commercial Distribution

  • 00889795070883 ()
P10-310-I107-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795070876

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 6MM, NEUTRAL
Paragon 28, Inc.
P10-310-I106-S
In Commercial Distribution

  • 00889795070876 ()
P10-310-I106-S

  • Fixed-bearing total ankle prosthesis

Optimotion Blue CR HCCR Total Knee System - B6961014P18190

Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 8, Thickness 19mm
OPTIMOTION IMPLANTS LLC
1014-P-1819
In Commercial Distribution

  • B6961014P18190 ()


  • Cruciate-retaining total knee prosthesis

Optimotion Blue CR HCCR Total Knee System - B6961014P18170

Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 8, Thickness 17mm
OPTIMOTION IMPLANTS LLC
1014-P-1817
In Commercial Distribution

  • B6961014P18170 ()


  • Cruciate-retaining total knee prosthesis

Optimotion Blue CR HCCR Total Knee System - B6961014P18150

Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 8, Thickness 15mm
OPTIMOTION IMPLANTS LLC
1014-P-1815
In Commercial Distribution

  • B6961014P18150 ()


  • Cruciate-retaining total knee prosthesis
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