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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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The Integra External Fixation System footplate is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224110
In Commercial Distribution

  • 10381780125570 ()

  • 140 mm inner dia
12224110

  • External orthopaedic fixation system, reusable
A crossbar is manufactured from stainless steel and aluminum. It may be attached to the anterior ring for additional support.
Ascension Orthopedics, Inc.
12225032
In Commercial Distribution

  • 10381780125556 ()

  • 160mm/180mm
12225032

  • External orthopaedic fixation system, reusable
A crossbar is manufactured from stainless steel and aluminum. It may be attached to the anterior ring for additional support.
Ascension Orthopedics, Inc.
12225030
In Commercial Distribution

  • 10381780125549 ()

  • 140mm/160mm
12225030

  • External orthopaedic fixation system, reusable
The Integra External Fixation System anterior half ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224124
In Commercial Distribution

  • 10381780125532 ()

  • 180 mm inner dia
12224124

  • External orthopaedic fixation system, reusable
The Integra External Fixation System full ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224122
In Commercial Distribution

  • 10381780125518 ()

  • 180 mm inner dia
12224122

  • External orthopaedic fixation system, reusable
The Integra External Fixation System footplate is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224120
In Commercial Distribution

  • 10381780125495 ()

  • 180 mm inner dia
12224120

  • External orthopaedic fixation system, reusable
The Integra External Fixation System anterior half ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224104
In Commercial Distribution

  • 10381780125488 ()

  • 160 mm inner dia
12224104

  • External orthopaedic fixation system, reusable
The Integra External Fixation System half ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224103
In Commercial Distribution

  • 10381780125471 ()

  • 160 mm inner dia
12224103

  • External orthopaedic fixation system, reusable
The Integra External Fixation System 5/8 ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224101
In Commercial Distribution

  • 10381780125457 ()

  • 160 mm inner dia
12224101

  • External orthopaedic fixation system, reusable
The universal joint is made from stainless steel. It is used to aid in the assembly of the Integra External Fixation System.
Ascension Orthopedics, Inc.
12225221
In Commercial Distribution

  • 10381780125433 ()

  • 1.28 in L
12225221

  • External orthopaedic fixation system, reusable
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