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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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Optimotion Blue CR HCCR Total Knee System - B6961014P11170

Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 1, Thickness 17mm
OPTIMOTION IMPLANTS LLC
1014-P-1117
In Commercial Distribution

  • B6961014P11170 ()


  • Cruciate-retaining total knee prosthesis

Optimotion Blue CR HCCR Total Knee System - B6961014P11150

Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 1, Thickness 15mm
OPTIMOTION IMPLANTS LLC
1014-P-1115
In Commercial Distribution

  • B6961014P11150 ()


  • Cruciate-retaining total knee prosthesis

Optimotion Blue CR HCCR Total Knee System - B6961014P11130

Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 1, Thickness 13mm
OPTIMOTION IMPLANTS LLC
1014-P-1113
In Commercial Distribution

  • B6961014P11130 ()


  • Cruciate-retaining total knee prosthesis

Optimotion Blue CR HCCR Total Knee System - B6961014P11110

Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 1, Thickness 11mm
OPTIMOTION IMPLANTS LLC
1014-P-1111
In Commercial Distribution

  • B6961014P11110 ()


  • Cruciate-retaining total knee prosthesis

Optimotion Blue CR HCCR Total Knee System - B6961014P11090

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 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 - 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 - 00889795076304

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
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